Morphine Sulfate
Tablet, Film Coated, Extended Release · Oral, Intravenous, Intramuscular
Current shortage
Morphine Sulfate, Injection, 50 mg/1 mL (NDC 0409-1896-20) – Unavailable (Hospira, Inc., a Pfizer Company, updated Sep 9, 2026)
Next Delivery: January 2027; Estimated Recovery: March 2027; Shortage per Manufacturer: Manufacturing Delay
Morphine Sulfate, Injection, 8 mg/1 mL (NDC 0641-6126-25) – unavailable (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released.
Morphine Sulfate, Injection, 4 mg/1 mL (NDC 76045-005-11) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Next release September 2026. Check wholesalers for inventory.
Morphine Sulfate, Injection, 5 mg/1 mL (NDC 63323-455-01) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD
Morphine Sulfate, Injection, 2 mg/1 mL (NDC 0409-1890-23) – Limited Availability (Hospira, Inc., a Pfizer Company, updated Sep 9, 2026)
Limited Supply Available. Next Delivery: November 2026; Estimated Recovery: December 2026; Shortage per Manufacturer: Manufacturing Delay
Morphine Sulfate, Injection, 2 mg/1 mL (NDC 76045-004-11) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Next release September 2026. Check wholesalers for inventory.
Morphine Sulfate, Injection, 10 mg/10 mL (1 mg/mL) (NDC 0409-3815-12) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Morphine Sulfate, Injection, 2 mg/1 mL Syringes (NDC 0409-1890-01) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Morphine Sulfate, Injection, 10 mg/1 mL Syringes (NDC 0409-1893-01) – Unavailable (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Discontinuation of the manufacture of the drug
Morphine Sulfate, Injection, 4 mg/1 mL (NDC 0641-6125-25) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots are scheduled to be manufactured. Product will be made available as it is released.
Uses
Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use :
• Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use
• Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )], and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Dosage and administration
• Morphine Sulfate Injection should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 )
• Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Morphine Sulfate Injection for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 )
• Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 )
• Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 )
• Respiratory depression can occur at any time during opioid therapy, especially when initiating the following dosage increases with Morphine Sulfate Injection. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 )
• Direct Intravenous Injection : Initiate treatment with 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain. ( 2.2 )
• Intramuscular Injection : Initiate treatment with 10 mg, every 4 hours as needed to manage pain (based on a 70 kg adult). ( 2.2 )
• Periodically reassess patients receiving Morphine Sulfate Injection to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.3 )
• Do not rapidly reduce or abruptly discontinue Morphine Sulfate Injection in a physically-dependent patient. ( 2.4 , 5.14 ) 2.1 Important Dosage and Administration Instructions
• Morphine Sulfate Injection is intended for intravenous and intramuscular administration.
• Morphine Sulfate Injection is available in two concentrations for direct injection. Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with morphine injections of different concentrations when prescribing, dispensing, and administering Morphine Sulfate Injection. Ensure that the dose is communicated and dispensed accurately.
• Administration of Morphine Sulfate Injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.
• Morphine Sulfate Injection should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.
• Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Morphine Sulfate Injection for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
• Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available.
• There is a variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions ( 5.1 )].
• Respiratory depression can occur at any time during opioid therapy, especially when initiating the following dosage increases with Morphine Sulfate Injection. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions ( 5 )].
• Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration. 2.2 Initial Dosage Direct Intravenous Injection Initiate treatment with Morphine Sulfate Injection in adults at a dosing range of 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain, and at the lowest dose necessary to achieve adequate analgesia. Administer the injection slowly. Intramuscular Injection The initial intramuscular dose is 10 mg every 4 hours (based on a 70 kg adult) as needed to manage pain, and at the lowest dose necessary to achieve adequate analgesia. 2.3 Titration and Maintenance of Therapy Titrate the dose based upon individual patient’s response to their initial dose of Morphine Sulfate Injection. Individually titrate Morphine Sulfate Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Morphine Sulfate Injection to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions ( 5.1 , 5.14 )] . If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Morphine Sulfate Injection dosage. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions ( 5 )] .
Dosage forms and strengths
Morphine Sulfate Injection, USP, is a sterile, preservative-free, clear, colorless to pale yellow solution. Morphine Sulfate Injection, USP, is available in the following strengths for intravenous (IV) and intramuscular (IM) administration in a 1 mL single-dose prefilled syringe: 1 mg/0.5 mL, 2 mg/mL, and 4 mg/mL. Injection, 1 mg/0.5 mL, 2 mg/mL and 4 mg/mL in a 1 mL single-dose prefilled syringe, for intravenous or intramuscular use. ( 3 )
Contraindications
Morphine Sulfate Injection is contraindicated in patients with:
• Significant respiratory depression [see Warnings and Precautions ( 5.2 )]
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.7 )]
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions ( 5.8 )].
• Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.12 )]
• Hypersensitivity to morphine (e.g., anaphylaxis) [see Adverse Reactions ( 6 )]
• Significant respiratory depression. ( 4 )
• Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 )
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. ( 4 )
• Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 )
• Hypersensitivity to morphine. ( 4 )
Warnings and precautions
• Cardiovascular Instability : High doses are excitatory. Have naloxone injection and resuscitative equipment immediately available. ( 5.5 )
• Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.6 )
• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Monitor closely, particularly during initiation and titration. ( 5.7 )
• Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 )
• Severe Hypotension : Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. ( 5.10 )
• Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousnes s: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. ( 5.11 ) 5.1 Addiction, Abuse, and Misuse Morphine Sulfate Injection contains morphine, a Schedule II controlled substance. As an opioid, Morphine Sulfate Injection exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence ( 9 )] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Morphine Sulfate Injection. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions ( 6.2 )] . Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Morphine Sulfate Injection, and monitor all patients receiving morphine sulfate for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Morphine Sulfate Injection, but use in such patients necessitates intensive counseling about the risks and proper use of Morphine Sulfate Injection, along with intensive monitoring for signs of addiction, abuse, and misuse. Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing Morphine Sulfate Injection. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity. Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.2 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical status [see Overdosage ( 10 )]. Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Morphine Sulfate Injection, the risk is greatest during the initiation of therapy or following a dosage increase. Because of a delay in the maximum CNS effect with intravenously administered Morphine Sulfate Injection (30 min), rapid administration may result in overdosing. The respiratory depression may be severe and could require intervention [see Overdosage ( 10 )] . To reduce the risk of respiratory depression, proper dosing and titration of Morphine Sulfate Injection are essential [see Dosage and Administration ( 2 )] . Overestimating the Morphine Sulfate Injection dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration ( 2.4 )]. 5.3 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Morphine Sulfate Injection with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone.
Side effects
The following serious adverse reactions are described, or described in greater detail, in other sections:
• Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )]
• Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )]
• Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.3 )]
• Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )]
• Cardiovascular Instability [see Warnings and Precautions ( 5.5 )]
• Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.6 )]
• Adrenal Insufficiency [see Warnings and Precautions ( 5.9 )]
• Severe Hypotension [see Warnings and Precautions ( 5.10 )]
• Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.12 )]
• Seizures [see Warnings and Precautions ( 5.13 )]
• Withdrawal [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions associated with Morphine Sulfate Injection included respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously. The most frequently observed adverse reactions included sedation, lightheadedness, dizziness, nausea, vomiting, constipation, and diaphoresis. Other possible adverse reactions include: Central Nervous System : Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, visual disturbances, transient hallucinations and disorientation. Gastrointestinal : Constipation, biliary tract spasm. Cardiovascular : Tachycardia, bradycardia, palpitation, faintness, syncope, and orthostatic hypotension. Genitourinary : Oliguria and urinary retention; an antidiuretic effect has been reported. Allergic : Pruritus, urticaria, and skin rashes. Anaphylactoid reactions have been reported following intravenous administration. Other : Opioid-induced histamine release may be responsible for the flushing of the face, diaphoresis, and pruritus often seen with these drugs. Wheals and urticaria at the site of injection are probably related to histamine release. Local tissue irritation, pain and induration have been reported following repeated subcutaneous injection. Morphine may alter temperature regulation in susceptible individuals and will depress the cough reflex. Androgen deficiency : Cases of androgen deficiency have occurred with use of opioids for an extended period of time [see Clinical Pharmacology ( 12.2 )] . Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions ( 5.6 )] Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Morphine Sulfate Injection. Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Hypoglycemia : Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes). Opioid-induced esophageal dysfunction (OIED) : Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term [see Warnings and Precautions ( 5.12 )] . Adverse Reactions from Observational Studies A prospective, observational cohort study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021. Study participants included in one or more analyses had been enrolled in selected insurance plans or health systems for at least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either: 1) filled multiple extended-release/long-acting opioid analgesic prescriptions during a 90-day period (n=978); or 2) filled any Schedule II opioid analgesic prescriptions covering at least 70 of 90 days (n=1,244). Those included also had no dispensing of the qualifying opioids in the previous 6 months. Over 12 months:
• approximately 1% to 6% of participants across the two cohorts newly met criteria for addiction, as assessed with two validated interview-based measures of moderate-to-severe opioid use disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, and
• approximately 9% and 22% of participants across the two cohorts newly met criteria for prescription opioid abuse and misuse [defined in Drug Abuse and Dependence ( 9.2 )] , respectively, as measured with a validated self-reported instrument. A retrospective, observational cohort study estimated the risk of opioid-involved overdose or opioid overdose-related death in patients with new long-term use of Schedule II opioid analgesics from 2006 through 2016 (n=220,249). Included patients had been enrolled in either one of two commercial insurance programs, one managed care program, or one Medicaid program for at least 9 months. New long-term use was defined as having Schedule II opioid analgesic prescriptions covering at least 70 days’ supply over the 3 months prior to study entry and none during the preceding 6 months. Patients were excluded if they had an opioid-involved overdose in the 9 months prior to study entry.
Drug interactions
Table 1 includes clinically significant drug interactions with Morphine Sulfate Injection. Table 1: Clinically Significant Drug Interactions with Morphine Sulfate Injection Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions ( 5.3 )] . Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation [see Warnings and Precautions ( 5.3 )] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions ( 5.8 )]. Intervention: Do not use Morphine Sulfate Injection in patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of Morphine Sulfate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Morphine Sulfate Injection and/or the muscle relaxant as necessary. Examples: cyclobenzaprine, metaxalone Cimetidine Clinical Impact: The concomitant administration of morphine sulfate and cimetidine has been reported to precipitate apnea, confusion, and muscle twitching in an isolated report. Intervention: Monitor patients for increased respiratory and CNS depression when receiving cimetidine concomitantly with Morphine Sulfate Injection. Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when Morphine Sulfate Injection is used concomitantly with anticholinergic drugs. Oral P2Y 12 Inhibitors Clinical Impact: The co-administration of oral P2Y 12 inhibitors and intravenous morphine sulfate can decrease the absorption and peak concentration of oral P2Y 12 inhibitors and delay the onset of antiplatelet effect. Intervention: Consider the use of a parenteral antiplatelet agent in the setting of acute coronary syndrome requiring co-administration of intravenous morphine sulfate. Examples: clopidogrel, prasugrel, ticagrelor
• Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. ( 7 )
• Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics : Avoid use with Morphine Sulfate Injection because they may reduce analgesic effect of Morphine Sulfate Injection or precipitate withdrawal symptoms. ( 7 )
Use in specific populations
Pregnancy : May cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )]. There are no available data with Morphine Sulfate Injection in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data ]. In published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (HDD) in hamsters and mice, respectively, lower fetal body weight and increased incidence of abortion at 0.4 times the HDD in the rabbit, growth retardation at 6 times the HDD in the rat, and axial skeletal fusion and cryptorchidism at 16 times the HDD in the mouse. Administration of morphine sulfate to pregnant rats during organogenesis and through lactation resulted in cyanosis, hypothermia, decreased brain weights, pup mortality, decreased pup body weights, and adverse effects on reproductive tissues at 3-4 times the HDD; and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the HDD [see Animal Data ] . Based on animal data, advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions ( 5.4 )] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Morphine Sulfate Injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Morphine Sulfate Injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Human Data The results from a population-based prospective cohort, including 70 women exposed to morphine during the first trimester of pregnancy and 448 women exposed to morphine at any time during pregnancy, indicate no increased risk for congenital malformations. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including small sample size and non-randomized study design. Animal Data Formal reproductive and developmental toxicology studies for morphine have not been conducted. Exposure margins for the following published study reports are based on human daily dose of 60 mg morphine using a body surface area comparison (HDD). Neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of morphine sulfate (35-322 mg/kg) on Gestation Day 8 to pregnant hamsters (4.7 to 43.5 times the HDD). A no adverse effect level was not defined in this study and the findings cannot be clearly attributed to maternal toxicity. Neural tube defects (exencephaly), axial skeletal fusions, and cryptorchidism were reported following a single subcutaneous (SC) injection of morphine sulfate to pregnant mice (100-500 mg/kg) on Gestation Day 8 or 9 at 200 mg/kg or greater (16 times the HDD) and fetal resorption at 400 mg/kg or higher (32 times the HDD). No adverse effects were noted following 100 mg/kg morphine in this model (8 times the HDD). In one study, following continuous subcutaneous infusion of doses greater than or equal to 2.72 mg/kg to mice (0.2 times the HDD), exencephaly, hydronephrosis, intestinal hemorrhage, split supraoccipital, malformed sternebrae, and malformed xiphoid were noted. The effects were reduced with increasing daily dose; possibly due to rapid induction of tolerance under these infusion conditions. The clinical significance of this report is not clear. Decreased fetal weights were observed in pregnant rats treated with 20 mg/kg/day morphine sulfate (3.2 times the HDD) from Gestation Day 7 to 9. There was no evidence of malformations despite maternal toxicity (10% mortality).
Pregnancy
8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.4 )]. There are no available data with Morphine Sulfate Injection in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data ]. In published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (HDD) in hamsters and mice, respectively, lower fetal body weight and increased incidence of abortion at 0.4 times the HDD in the rabbit, growth retardation at 6 times the HDD in the rat, and axial skeletal fusion and cryptorchidism at 16 times the HDD in the mouse. Administration of morphine sulfate to pregnant rats during organogenesis and through lactation resulted in cyanosis, hypothermia, decreased brain weights, pup mortality, decreased pup body weights, and adverse effects on reproductive tissues at 3-4 times the HDD; and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the HDD [see Animal Data ] . Based on animal data, advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions ( 5.4 )] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Morphine Sulfate Injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Morphine Sulfate Injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Human Data The results from a population-based prospective cohort, including 70 women exposed to morphine during the first trimester of pregnancy and 448 women exposed to morphine at any time during pregnancy, indicate no increased risk for congenital malformations. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including small sample size and non-randomized study design. Animal Data Formal reproductive and developmental toxicology studies for morphine have not been conducted. Exposure margins for the following published study reports are based on human daily dose of 60 mg morphine using a body surface area comparison (HDD). Neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of morphine sulfate (35-322 mg/kg) on Gestation Day 8 to pregnant hamsters (4.7 to 43.5 times the HDD). A no adverse effect level was not defined in this study and the findings cannot be clearly attributed to maternal toxicity. Neural tube defects (exencephaly), axial skeletal fusions, and cryptorchidism were reported following a single subcutaneous (SC) injection of morphine sulfate to pregnant mice (100-500 mg/kg) on Gestation Day 8 or 9 at 200 mg/kg or greater (16 times the HDD) and fetal resorption at 400 mg/kg or higher (32 times the HDD). No adverse effects were noted following 100 mg/kg morphine in this model (8 times the HDD). In one study, following continuous subcutaneous infusion of doses greater than or equal to 2.72 mg/kg to mice (0.2 times the HDD), exencephaly, hydronephrosis, intestinal hemorrhage, split supraoccipital, malformed sternebrae, and malformed xiphoid were noted. The effects were reduced with increasing daily dose; possibly due to rapid induction of tolerance under these infusion conditions. The clinical significance of this report is not clear. Decreased fetal weights were observed in pregnant rats treated with 20 mg/kg/day morphine sulfate (3.2 times the HDD) from Gestation Day 7 to 9. There was no evidence of malformations despite maternal toxicity (10% mortality). In a second rat study, decreased fetal weight and increased incidences of growth retardation were noted at 35 mg/kg/day (5.7 times the HDD) and there was a reduced number of fetuses at 70 mg/kg/day (11.4 times the HDD) when pregnant rats were treated with 10, 35, or 70 mg/kg/day morphine sulfate via continuous infusion from Gestation Day 5 to 20.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of Morphine Sulfate Injection in pediatric patients below the age of 18 have not been established.
Geriatric use
8.5 Geriatric Use The pharmacodynamic effects of morphine in the elderly are more variable than in the younger population. Older patients will vary widely in the effective initial dose, rate of development of tolerance and the frequency and magnitude of associated adverse effects as the dose is increased. Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Morphine Sulfate Injection slowly in geriatric patients and monitor for signs of central nervous system and respiratory depression [see Warnings and Precautions ( 5.7 )] . Morphine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Overdosage
Clinical Presentation Acute overdose with morphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology ( 12.2 )] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. For clinically significant respiratory or circulatory depression secondary to morphine overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of morphine in Morphine Sulfate Injection, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product's prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the reversal agent administered. If a decision is made to treat serious respiratory depression in the physically-dependent patient, administration of the reversal agent should begin with care and by titration with smaller than usual doses of the reversal agent.
Description
Morphine Sulfate Injection, USP, contains morphine, an opioid agonist, in the form of sulfate salt which is isolated as morphine sulfate pentahydrate. The chemical name for Morphine sulfate pentahydrate is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6 α-diol sulfate (2: 1) (salt) pentahydrate. The molecular formula is (C 17 H 19 NO 3 ) 2
• H 2 SO 4
• 5H 2 O and the molecular weight is 758.83. The chemical structure of Morphine sulfate pentahydrate is: Morphine sulfate pentahydrate is a fine white powder. When exposed to air, it gradually loses water of hydration, and darkens on prolonged exposure to light. It is soluble in water and ethanol at room temperature. Morphine Sulfate Injection, USP, for intravenous and intramuscular administration, is a sterile, nonpyrogenic solution of Morphine Sulfate, free of antioxidants and preservatives. It is available in single-dose prefilled syringes, in the following strengths:
• For the 1 mg/0.5 mL product: Each single-dose prefilled syringe contains 1 mg Morphine Sulfate pentahydrate (equivalent to 0.75 mg Morphine), 0.03 mg of calcium chloride, 0.06 mg of edetate sodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents in 0.5 mL water for injection.
• For the 2 mg/mL and 4 mg/mL products: Each single-dose prefilled syringe contains 2 mg (equivalent to 1.50 mg Morphine) or 4 mg (equivalent to 3.01 mg of Morphine) of Morphine Sulfate pentahydrate, 0.053 mg of calcium chloride, 0.111 mg of edetate disodium, sodium chloride to adjust tonicity, citric acid and sodium citrate as buffering agents, in 1 mL water for injection. The pH of Morphine Sulfate Injection is 2.5 to 6.5. morph-struc-01.jpg
Mechanism of action
12.1 Mechanism of Action Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
How supplied
Morphine Sulfate Injection, USP, for intravenous (IV) or intramuscular (IM) use, is a sterile, preservative-free, clear, colorless to pale yellow solution, available as: Product Code Unit of Sale Strength Each 764406 NDC 76045-238-10 Unit of 10 1 mg/0.5 mL NDC 76045-238-01 1 mL single-dose prefilled syringe 764411 NDC 76045-004-11 Unit of 10 2 mg/mL NDC 76045-004-01 1 mL single-dose prefilled syringe 764511 NDC 76045-005-11 Unit of 10 4 mg/mL NDC 76045-005-01 1 mL single-dose prefilled syringe Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. DO NOT FREEZE.
Patient information
Addiction, Abuse, and Misuse Inform patients that the use of Morphine Sulfate Injection, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions ( 5.1 )] . Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Morphine Sulfate Injection or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions ( 5.2 )] . Hyperalgesia and Allodynia Advise patients to inform their healthcare provider if they experience symptoms of hyperalgesia, including worsening pain, increased sensitivity to pain, or new pain [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6 )]. Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition called serotonin syndrome resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop after discharge from the hospital. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Drug Interactions ( 7 )] . Constipation Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions ( 6 )] .
Label text from the FDA structured product label by Fresenius Kabi, USA LLC (revised Aug 31, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Morphine Sulfate in 141 products
Morphine Sulfate NDC products (141)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0228-3117 | Morphine Sulfate 75 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3116 | Morphine Sulfate 45 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3093 | Morphine Sulfate 120 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3092 | Morphine Sulfate 90 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3091 | Morphine Sulfate 60 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3090 | Morphine Sulfate 30 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 68084-158 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA · DEA CII |
| 60687-617 | Morphine Sulfate 15 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 60687-927 | Morphine Sulfate 10 mg/5mL Solution | American Health Packaging | ANDA · DEA CII |
| 68000-110 | Morphine Sulfate 20 mg/mL Solution | American Health Packaging | ANDA · DEA CII |
| 68000-111 | Morphine Sulfate 20 mg/mL Solution | American Health Packaging | ANDA · DEA CII |
| 68000-112 | Morphine Sulfate 20 mg/mL Solution | American Health Packaging | ANDA · DEA CII |
| 68000-113 | Morphine Sulfate 20 mg/mL Solution | American Health Packaging | ANDA · DEA CII |
| 68000-114 | Morphine Sulfate 20 mg/mL Solution | American Health Packaging | ANDA · DEA CII |
| 68084-157 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA · DEA CII |
| 0115-1479 | Morphine Sulfate 40 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1282 | Morphine Sulfate 100 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1281 | Morphine Sulfate 80 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1277 | Morphine Sulfate 20 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1278 | Morphine Sulfate 30 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1279 | Morphine Sulfate 50 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1280 | Morphine Sulfate 60 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 67877-671 | Morphine Sulfate 30 mg/1 Tablet | Ascend Laboratories, LLC | ANDA · DEA CII |
| 67877-670 | Morphine Sulfate 15 mg/1 Tablet | Ascend Laboratories, LLC | ANDA · DEA CII |
| 63629-4483 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1793 | Morphine Sulfate 60 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-8505 | Morphine Sulfate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-8459 | Morphine Sulfate 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-4484 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1791 | Morphine Sulfate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2302 | Morphine Sulfate 20 mg/mL Solution | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2301 | Morphine Sulfate 20 mg/mL Solution | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1091 | Morphine Sulfate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1089 | Morphine Sulfate 60 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1088 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1087 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1792 | Morphine Sulfate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1790 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1789 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1352 | Morphine Sulfate 200 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1282 | Morphine Sulfate 20 mg/mL Solution | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-9662 | Morphine Sulfate 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-3080 | Morphine Sulfate 100 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-0676 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-0707 | Morphine Sulfate 60 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-0736 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72572-440 | Morphine Sulfate 4 mg/mL Injection | Civica, Inc. | ANDA · DEA CII |
| 27808-082 | Morphine Sulfate 20 mg/mL Solution | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 0641-6192 | Morphine Sulfate 4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6191 | Morphine Sulfate 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6127 | Morphine Sulfate 10 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6126 | Morphine Sulfate 8 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6125 | Morphine Sulfate 4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0409-3814 | Morphine Sulfate .5 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CII |
| 0409-3815 | Morphine Sulfate 1 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CII |
| 76329-1912 | Morphine Sulfate 1 mg/30mL Injection | International Medication Systems, Limited | ANDA · DEA CII |
| 43386-544 | Morphine Sulfate 200 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-541 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-543 | Morphine Sulfate 100 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-542 | Morphine Sulfate 60 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-540 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 0904-6557 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA · DEA CII |
| 0904-6558 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA · DEA CII |
| 0904-6559 | Morphine Sulfate 60 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA · DEA CII |
| 0904-6560 | Morphine Sulfate 100 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA · DEA CII |
| 42689-009 | Morphine Sulfate 80 mg/1 Capsule, Extended Release | Nortec Development Associates, Inc. | ANDA · DEA CII |
| 42689-008 | Morphine Sulfate 60 mg/1 Capsule, Extended Release | Nortec Development Associates, Inc. | ANDA · DEA CII |
| 42689-005 | Morphine Sulfate 20 mg/1 Capsule, Extended Release | Nortec Development Associates, Inc. | ANDA · DEA CII |
| 42689-006 | Morphine Sulfate 30 mg/1 Capsule, Extended Release | Nortec Development Associates, Inc. | ANDA · DEA CII |
| 42689-007 | Morphine Sulfate 50 mg/1 Capsule, Extended Release | Nortec Development Associates, Inc. | ANDA · DEA CII |
| 42689-010 | Morphine Sulfate 100 mg/1 Capsule, Extended Release | Nortec Development Associates, Inc. | ANDA · DEA CII |
| 0121-4955 | Morphine Sulfate 10 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA · DEA CII |
| 67296-2122 | Morphine Sulfate 15 mg/1 Tablet | Redpharm Drug | ANDA · DEA CII |
| 42858-804 | Morphine Sulfate 100 mg/1 Tablet, Film Coated, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-803 | Morphine Sulfate 60 mg/1 Tablet, Film Coated, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-802 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-801 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-805 | Morphine Sulfate 200 mg/1 Tablet, Film Coated, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 0406-5118 | Morphine Sulfate 15 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-8390 | Morphine Sulfate 100 mg/1 Tablet, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 0406-8380 | Morphine Sulfate 60 mg/1 Tablet, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 0406-5119 | Morphine Sulfate 30 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-8003 | Morphine Sulfate 20 mg/mL Solution | SpecGx LLC | ANDA · DEA CII |
| 0406-8315 | Morphine Sulfate 15 mg/1 Tablet, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 0406-8320 | Morphine Sulfate 200 mg/1 Tablet, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 0406-8330 | Morphine Sulfate 30 mg/1 Tablet, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 60760-893 | Morphine Sulfate 15 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CII |
| 63304-450 | Morphine Sulfate 15 mg/1 Tablet, Film Coated, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 63304-758 | Morphine Sulfate 60 mg/1 Tablet, Film Coated, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 63304-453 | Morphine Sulfate 200 mg/1 Tablet, Film Coated, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 63304-452 | Morphine Sulfate 100 mg/1 Tablet, Film Coated, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 63304-451 | Morphine Sulfate 30 mg/1 Tablet, Film Coated, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 0832-0225 | Morphine Sulfate 10 mg/1 Capsule, Extended Release | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0226 | Morphine Sulfate 20 mg/1 Capsule, Extended Release | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0227 | Morphine Sulfate 30 mg/1 Capsule, Extended Release | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0228 | Morphine Sulfate 50 mg/1 Capsule, Extended Release | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0274 | Morphine Sulfate 30 mg/1 Tablet | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0273 | Morphine Sulfate 15 mg/1 Tablet | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0229 | Morphine Sulfate 60 mg/1 Capsule, Extended Release | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0230 | Morphine Sulfate 80 mg/1 Capsule, Extended Release | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0832-0233 | Morphine Sulfate 100 mg/1 Capsule, Extended Release | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 75826-131 | Morphine Sulfate 100 mg/5mL Solution | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-130 | Morphine Sulfate 20 mg/5mL Solution | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-129 | Morphine Sulfate 10 mg/5mL Solution | Winder Laboratories LLC | ANDA · DEA CII |
| 60687-760 | Morphine Sulfate 10 mg/5mL Solution | American Health Packaging | NDA · DEA CII |
| 63323-458 | Morphine Sulfate 8 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 63323-455 | Morphine Sulfate 5 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 63323-454 | Morphine Sulfate 4 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 63323-452 | Morphine Sulfate 2 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 63323-451 | Morphine Sulfate 10 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 76045-004 | Morphine Sulfate 2 mg/mL Injection, Solution | Fresenius Kabi, USA LLC | NDA · DEA CII |
| 76045-005 | Morphine Sulfate 4 mg/mL Injection, Solution | Fresenius Kabi, USA LLC | NDA · DEA CII |
| 76045-006 | Morphine Sulfate 5 mg/mL Injection, Solution | Fresenius Kabi, USA LLC | NDA · DEA CII |
| 76045-007 | Morphine Sulfate 8 mg/mL Injection, Solution | Fresenius Kabi, USA LLC | NDA · DEA CII |
| 76045-008 | Morphine Sulfate 10 mg/mL Injection, Solution | Fresenius Kabi, USA LLC | NDA · DEA CII |
| 76045-238 | Morphine Sulfate 1 mg/.5mL Injection, Solution | Fresenius Kabi, USA LLC | NDA · DEA CII |
| 0054-0238 | Morphine Sulfate 20 mg/5mL Solution | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0054-0517 | Morphine Sulfate 100 mg/5mL Solution | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0054-0235 | Morphine Sulfate 15 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0054-0237 | Morphine Sulfate 10 mg/5mL Solution | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0054-0236 | Morphine Sulfate 30 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0409-2022 | Morphine Sulfate 50 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-1896 | Morphine Sulfate 50 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-1893 | Morphine Sulfate 10 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-1891 | Morphine Sulfate 4 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-1890 | Morphine Sulfate 2 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0121-0904 | Morphine Sulfate 10 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | NDA · DEA CII |
| 68094-001 | Morphine Sulfate 10 mg/5mL Solution | Precision Dose Inc. | NDA · DEA CII |
| 68094-356 | Morphine Sulfate 100 mg/5mL Solution | Precision Dose, Inc. | NDA · DEA CII |
| 68094-045 | Morphine Sulfate 100 mg/5mL Solution | Precision Dose, Inc. | NDA · DEA CII |
| 68094-056 | Morphine Sulfate 100 mg/5mL Solution | Precision Dose, Inc. | NDA · DEA CII |
| 68094-156 | Morphine Sulfate 100 mg/5mL Solution | Precision Dose, Inc. | NDA · DEA CII |
| 68094-556 | Morphine Sulfate 100 mg/5mL Solution | Precision Dose, Inc. | NDA · DEA CII |
| 63629-2535 | Morphine Sulfate 10 mg/1 Suppository | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CII |
| 63629-2536 | Morphine Sulfate 20 mg/1 Suppository | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CII |
| 63629-2538 | Morphine Sulfate 30 mg/1 Suppository | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CII |
| 63629-2537 | Morphine Sulfate 5 mg/1 Suppository | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CII |
| 0574-7110 | Morphine Sulfate 5 mg/1 Suppository | Padagis US LLC | UNAPPROVED DRUG OTHER · DEA CII |
| 0574-7112 | Morphine Sulfate 10 mg/1 Suppository | Padagis US LLC | UNAPPROVED DRUG OTHER · DEA CII |
| 0574-7114 | Morphine Sulfate 20 mg/1 Suppository | Padagis US LLC | UNAPPROVED DRUG OTHER · DEA CII |
| 0574-7116 | Morphine Sulfate 30 mg/1 Suppository | Padagis US LLC | UNAPPROVED DRUG OTHER · DEA CII |
Morphine Sulfate recalls
- D-0788-2026 Aug 26, 2026 · Class I · Ongoing
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. - D-0223-2026 Dec 17, 2025 · Class III · Ongoing
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. - D-0249-2025 Mar 12, 2025 · Class II · Ongoing
Failed Dissolution Specifications - D-0856-2021 Oct 6, 2021 · Class II · Terminated
Defective container: Cracked vials leading to lack of sterility assurance - D-1243-2019 May 1, 2019 · Class III · Terminated
Failed Impurities/Degradation Specifications - D-1244-2019 May 1, 2019 · Class III · Terminated
Failed Impurities/Degradation Specifications - D-1245-2019 May 1, 2019 · Class III · Terminated
Failed Impurities/Degradation Specifications - D-1246-2019 May 1, 2019 · Class III · Terminated
Failed Impurities/Degradation Specifications - D-1247-2019 May 1, 2019 · Class III · Terminated
Failed Impurities/Degradation Specifications - D-1214-2018 Sep 26, 2018 · Class III · Terminated
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and… - D-1126-2017 Sep 6, 2017 · Class II · Terminated
Defective container: Oral solution leaking from container. - D-308-2013 May 8, 2013 · Class II · Terminated
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Frequently asked questions
What is Morphine Sulfate used for?
Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use : • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics,…
What are the side effects of Morphine Sulfate?
The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.3 )] • Neonatal Opioid Withdrawal Syndrome [see… See the full label for the complete list.
Who makes Morphine Sulfate?
Morphine Sulfate is listed by 26 labelers in the FDA NDC directory, including Actavis Pharma, Inc., American Health Packaging, Amneal Pharmaceuticals of New York LLC, Ascend Laboratories, LLC.
Has Morphine Sulfate been recalled?
The FDA enforcement database lists 12 recalls for Morphine Sulfate, most recently D-0788-2026 (class i): Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.