Hydromorphone Hydrochloride
Tablet · Oral, Intramuscular, Intravenous
Current shortage
Hydromorphone Hydrochloride, Injection, 0.25 mg/ 0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-1805-01) – Unavailable (Hospira, Inc., a Pfizer Company, updated Sep 9, 2026)
Next Delivery and Estimated Recovery: December 2026; Shortage per Manufacturer: Manufacturing Delay
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0641-6254-01) – Unavailable (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Product temporarily on backorder. Additional lots will be available in the September 2026 timeframe.
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-3365-10) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0409-2634-01) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 63323-851-10) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Check wholesalers for inventory
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL (NDC 0409-1312-36) – Limited Availability (Hospira, Inc., a Pfizer Company, updated Sep 9, 2026)
Limited Supply Available. Next Delivery: January 2027; Estimated Recovery: March 2027; Shortage per Manufacturer: Manufacturing Delay
Hydromorphone Hydrochloride, Injection, 500 mg/50 mL (10 mg/mL) (NDC 0409-2634-50) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Hydromorphone Hydrochloride, Injection, 0.5 mg/0.5 mL NexJect™ Single-dose Syringe Luer Lock (no needle) (NDC 0409-4264-01) – Limited Supply Available. Next Delivery: September 2026; Est (Hospira, Inc., a Pfizer Company, updated Sep 9, 2026)
Limited Supply Available. Next Delivery: September 2026; Estimated Recovery: December 2026; Shortage per Manufacturer: Manufacturing Delay
Hydromorphone Hydrochloride, Injection, 50 mg/5 mL (10 mg/mL) (NDC 0409-2634-05) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL Syringes (NDC 0409-1312-30) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Uses
Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering Hydromorphone Hydrochloride Injection (HPF). 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 [see Warnings and Precautions ( 5.3 )] , reserve opioid analgesics, including Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydromorphone Hydrochloride Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. ( 1 ) Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is an opioid agonist indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg/hr of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when administering Hydromorphone Hydrochloride Injection (HPF). 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)], 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 , 5.2 )
Dosage and administration
• Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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 , 5.2 )
• Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF). Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.3 )
• Initial Dosage : - Intramuscular or Subcutaneous Use: The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary. ( 2.2 ) - Intravenous Use: The usual starting dose is 0.2 mg to 1 mg every 2 to 3 hours. The injection should be given slowly, over at least 2 to 3 minutes. ( 2.2 )
• Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is for opioid-tolerant patients only and should be used only if the amount of hydromorphone required can be delivered accurately with this formulation. ( 2.2 )
• Hepatic Impairment : Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment. ( 2.3 )
• Renal Impairment : Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment. ( 2.4 )
• Periodically reassess patients receiving Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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. ( 2.5 )
• Do not rapidly reduce or abruptly discontinue Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) in a physically-dependent patient. ( 2.6 , 5.13 ) 2.1 Important Dosage and Administration Instructions
• Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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 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 ( 5.2 )].
• Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF). Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions ( 5 )] .
• Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A slight yellowish discoloration may develop in Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) vials. No loss of potency has been demonstrated. Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) are physically compatible and chemically stable for at least 24 hours at 25°C, protected from light in most common large-volume parenteral solutions.
• Discard any unused portion in an appropriate manner. 500 mg/50 mL Vial To use this single dose presentation, withdraw the contents using aseptic technique for preparation of a single, large-volume parenteral solution. Discard any unused portion in an appropriate manner. 2.2 Initial Dosage Use of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] as the First Opioid Analgesic : Hydromorphone Hydrochloride Injection (HPF) is for use in opioid tolerant patients only. Do not use Hydromorphone Hydrochloride Injection (HPF) for patients who are not tolerant to the respiratory depressant or sedating effects of opioids.
Dosage forms and strengths
Hydromorphone Hydrochloride Injection: Each 1 mL colorless single dose vial contains 1 mg/mL, 2 mg/mL, or 4 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution. Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] (for use in opioid-tolerant patients only): Each amber single dose vial contains 10 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution and is available in 1 mL, 5 mL and 50 mL single dose vials.
• Hydromorphone Hydrochloride Injection, 1 mg/mL, 2 mg/mL, or 4 mg/mL in single dose colorless vials, and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)], 10 mg/mL, available in 1 mL, 5 mL, and 50 mL single dose amber vials. ( 3 )
Contraindications
Both Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] are contraindicated in patients with:
• Significant respiratory depression [see Warnings and Precautions ( 5.3 )]
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.7 )]
• Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.11 )]
• Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite containing medications (e.g., anaphylaxis) [see Warnings and Precautions ( 5.15 )] Hydromorphone Hydrochloride Injection (HPF) is contraindicated in patients who are not opioid tolerant [see Warnings and Precautions ( 5.1 )].
• Significant respiratory depression. ( 4 )
• Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 )
• Known or suspected gastrointestinal obstruction, including paralytic ileus.( 4 )
• Known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product. ( 4 )
• Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]: Patients who are not opioid tolerant. ( 4 )
Warnings and precautions
• 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. ( 5.8 )
• Severe Hypotension : Monitor during dosage initiation and titration. Avoid use of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in patients with circulatory shock. ( 5.9 )
• Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression. Avoid use of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) in patients with impaired consciousness or coma. ( 5.10 )
• Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) contain sodium metabisulfite. There is a risk of anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people. ( 5.15 ) 5.1 Risk of Medication Errors Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is a 10 mg/mL concentrated solution of hydromorphone, and is intended for use in opioid-tolerant patients only. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer. Do not confuse Hydromorphone Hydrochloride Injection (HPF) with standard parenteral formulations of Hydromorphone Hydrochloride Injection (1 mg/mL, 2 mg/mL, 4 mg/mL) or other opioids, as overdose and death could result. 5.2 Addiction, Abuse, and Misuse Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] contain hydromorphone, a Schedule II controlled substance. As an opioid, Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF). 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF), and monitor all patients receiving Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF), but use in such patients necessitates intensive counseling about the risks and proper use of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF). 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. 5.3 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)], the risk is greatest during the initiation of therapy or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) are essential [see Dosage and Administration ( 2 )].
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 ( 5.2 )]
• Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )]
• Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.4 )]
• Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.5 )]
• Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.6 )]
• Adrenal Insufficiency [see Warnings and Precautions ( 5.8 )]
• Severe Hypotension [see Warnings and Precautions ( 5.9 )]
• Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.11 )]
• Seizures [see Warnings and Precautions ( 5.12 )]
• Withdrawal [see Warnings and Precautions ( 5.13 )] The following adverse reactions associated with the use of hydromorphone 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 Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. The most common adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain. Less Frequently Observed Adverse Reactions Cardiac disorders: tachycardia, bradycardia, palpitations Eye disorders: vision blurred, diplopia, miosis, visual impairment Gastrointestinal disorders: constipation, ileus, diarrhea, abdominal pain General disorders and administration site conditions: weakness, feeling abnormal , chills, injection site urticaria, fatigue, injection site reactions, peripheral edema Hepatobiliary disorders: biliary colic Immune system disorders : anaphylactic reactions, hypersensitivity reactions Investigations: hepatic enzymes increased Metabolism and nutrition disorders: decreased appetite Musculoskeletal and connective tissue disorders: muscle rigidity Nervous system disorders: headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration , involuntary muscle contractions, presyncope, convulsion, drowsiness, dyskinesia, hyperalgesia, lethargy, myoclonus, somnolence Psychiatric disorders: agitation, mood altered, nervousness, anxiety , depression, hallucination, disorientation, insomnia, abnormal dreams Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects Reproductive system and breast disorders: erectile dysfunction Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm, dyspnea, oropharyngeal swelling Skin and subcutaneous tissue disorders: injection site pain, urticaria, rash, hyperhidrosis Vascular disorders: flushing, hypotension, hypertension 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. Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. 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 )] 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 ( 5.11 )] . 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.
Drug interactions
Table 1 includes clinically significant drug interactions with Hydromorphone Hydrochloride Injection and/or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. TABLE 1. Clinically Significant Drug Interactions with Hydromorphone Hydrochloride Injection and/or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] Benzodiazepines and other Central Nervous System Depressants (CNS) Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. [see Warnings and Precautions ( 5.4 )] 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 patients closely for signs of respiratory depression and sedation [see Warnings and Precautions ( 5.4 )]. 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 Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) 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 effect 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 ( 5.3 )]. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Intervention: The use of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) is not recommended for 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 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 Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) and/or precipitate withdrawal syndrome. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Hydromorphone 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 Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) and/or the muscle relaxant as necessary. Examples: cyclobenzaprine, metaxalone 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 Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF) are used concomitantly with anticholinergic drugs.
• Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue Hydromorphone Hydrochloride Injection or [high potency formulation (HPF)] if serotonin syndrome is suspected. ( 7 )
• Monoamine Oxidase Inhibitors (MAOIs) : Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. ( 7 )
• Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics : Avoid use with Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) because they may reduce analgesic effect of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) 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 may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.5 )] . There are no available data with Hydromorphone Hydrochloride Injection in pregnant women to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are adverse outcomes reported with fetal exposure to opioid analgesics (see Clinical Considerations ) . In animal reproduction studies, reduced postnatal survival of pups, and decreased body weight were noted following oral treatment of pregnant rats with hydromorphone during gestation and through lactation at doses 0.8 times the human daily dose of 24 mg/day (HDD), respectively. In published studies, neural tube defects were noted following subcutaneous injection of hydromorphone to pregnant hamsters at doses 6.4 times the HDD and soft tissue and skeletal abnormalities were noted following subcutaneous continuous infusion of 3 times the HDD to pregnant mice. No malformations were noted at 4 or 40.5 times the HDD in pregnant rats or rabbits, respectively [see Data ]. Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 ( 5.5 )]. 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. Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF), 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 Animal Data Pregnant rats were treated with hydromorphone hydrochloride from Gestation Day 6 to 17 via oral gavage doses of 1, 5, or 10 mg/kg/day (0.4, 2, or 4 times the HDD of 24 mg based on body surface area, respectively). Maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in the two highest dose groups). There was no evidence of malformations or embryotoxicity reported. Pregnant rabbits were treated with hydromorphone hydrochloride from Gestation Day 7 to 19 via oral gavage doses of 10, 25, or 50 mg/kg/day (8.1, 20.3, or 40.5 times the HDD of 24 mg based on body surface area, respectively). Maternal toxicity was noted in the two highest dose groups (reduced food consumption and body weights). There was no evidence of malformations or embryotoxicity reported. In a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of hydromorphone hydrochloride (19 to 258 mg/kg) on Gestation Day 8 to pregnant hamsters (6.4 to 87.2 times the HDD of 24 mg/day based on body surface area). The findings cannot be clearly attributed to maternal toxicity. No neural tube defects were noted at 14 mg/kg (4.7 times the human daily dose of 24 mg/day). In a published study, CF-1 mice were treated subcutaneously with continuous infusion of 7.5, 15, or 30 mg/kg/day hydromorphone hydrochloride (1.5, 3, or 6.1 times the human daily dose of 24 mg based on body surface area) via implanted osmotic pumps during organogenesis (Gestation Days 7 to 10). Soft tissue malformations (cryptorchidism, cleft palate, malformed ventricles and retina), and skeletal variations (split supraoccipital, checkerboard and split sternebrae, delayed ossification of the paws and ectopic ossification sites) were observed at doses 3 times the human dose of 24 mg/day based on body surface area. The findings cannot be clearly attributed to maternal toxicity. Increased pup mortality and decreased pup body weights were noted at 0.8 and 2 times the human daily dose of 24 mg in a study in which pregnant rats were treated with hydromorphone hydrochloride from Gestation Day 7 to Lactation Day 20 via oral gavage doses of 0, 0.5, 2, or 5 mg/kg/day (0.2, 0.8, or 2 times the HDD of 24 mg based on body surface area, respectively). Maternal toxicity (decreased food consumption and body weight gain) was also noted at the two highest doses tested. 8.2 Lactation Risk Summary Low levels of opioid analgesics have been detected in human milk.
Pregnancy
8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions ( 5.5 )] . There are no available data with Hydromorphone Hydrochloride Injection in pregnant women to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. There are adverse outcomes reported with fetal exposure to opioid analgesics (see Clinical Considerations ) . In animal reproduction studies, reduced postnatal survival of pups, and decreased body weight were noted following oral treatment of pregnant rats with hydromorphone during gestation and through lactation at doses 0.8 times the human daily dose of 24 mg/day (HDD), respectively. In published studies, neural tube defects were noted following subcutaneous injection of hydromorphone to pregnant hamsters at doses 6.4 times the HDD and soft tissue and skeletal abnormalities were noted following subcutaneous continuous infusion of 3 times the HDD to pregnant mice. No malformations were noted at 4 or 40.5 times the HDD in pregnant rats or rabbits, respectively [see Data ]. Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 ( 5.5 )]. 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. Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF), 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 Animal Data Pregnant rats were treated with hydromorphone hydrochloride from Gestation Day 6 to 17 via oral gavage doses of 1, 5, or 10 mg/kg/day (0.4, 2, or 4 times the HDD of 24 mg based on body surface area, respectively). Maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in the two highest dose groups). There was no evidence of malformations or embryotoxicity reported. Pregnant rabbits were treated with hydromorphone hydrochloride from Gestation Day 7 to 19 via oral gavage doses of 10, 25, or 50 mg/kg/day (8.1, 20.3, or 40.5 times the HDD of 24 mg based on body surface area, respectively). Maternal toxicity was noted in the two highest dose groups (reduced food consumption and body weights). There was no evidence of malformations or embryotoxicity reported. In a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of hydromorphone hydrochloride (19 to 258 mg/kg) on Gestation Day 8 to pregnant hamsters (6.4 to 87.2 times the HDD of 24 mg/day based on body surface area). The findings cannot be clearly attributed to maternal toxicity. No neural tube defects were noted at 14 mg/kg (4.7 times the human daily dose of 24 mg/day). In a published study, CF-1 mice were treated subcutaneously with continuous infusion of 7.5, 15, or 30 mg/kg/day hydromorphone hydrochloride (1.5, 3, or 6.1 times the human daily dose of 24 mg based on body surface area) via implanted osmotic pumps during organogenesis (Gestation Days 7 to 10). Soft tissue malformations (cryptorchidism, cleft palate, malformed ventricles and retina), and skeletal variations (split supraoccipital, checkerboard and split sternebrae, delayed ossification of the paws and ectopic ossification sites) were observed at doses 3 times the human dose of 24 mg/day based on body surface area. The findings cannot be clearly attributed to maternal toxicity. Increased pup mortality and decreased pup body weights were noted at 0.8 and 2 times the human daily dose of 24 mg in a study in which pregnant rats were treated with hydromorphone hydrochloride from Gestation Day 7 to Lactation Day 20 via oral gavage doses of 0, 0.5, 2, or 5 mg/kg/day (0.2, 0.8, or 2 times the HDD of 24 mg based on body surface area, respectively). Maternal toxicity (decreased food consumption and body weight gain) was also noted at the two highest doses tested.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in pediatric patients has not been established.
Geriatric use
8.5 Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to hydromorphone. 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions ( 5.7 )]. Hydromorphone 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 hydromorphone 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 airway 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 hydromorphone 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 hydromorphone in Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection (HPF), 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 be initiated with care and by titration with smaller than usual doses of the reversal agent.
Description
Hydromorphone Hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone Hydrochloride Injection is available as a sterile, aqueous solution in single dose colorless vials for slow intravenous, subcutaneous, or intramuscular administration. Each mL contains 1 mg, 2 mg, or 4 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH of between 3.5 and 5.5. Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is available as a sterile, aqueous solution in single dose amber vials for intravenous, subcutaneous, or intramuscular administration. Each single dose vial contains 10 mg/mL of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH of between 3.5 and 5.5. The chemical name of Hydromorphone Hydrochloride is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.80. Its molecular formula is C 17 H 19 NO 3 ꞏHCl, and it has the following chemical structure: Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. The inactive ingredients in Hydromorphone Hydrochloride Injection include: 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5. hydro-struc-01.jpg
Mechanism of action
12.1 Mechanism of Action Hydromorphone 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 hydromorphone 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
Hydromorphone Hydrochloride Injection Hydromorphone Hydrochloride Injection is supplied in single dose colorless vials. Each mL of sterile, aqueous solution contains 1 mg, 2 mg, or 4 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. Hydromorphone Hydrochloride Injection is preservative free and is supplied as follows: Product Code Unit of Sale Strength Each 852101 NDC 63323-852-25 Unit of 25 1 mg per mL NDC 63323-852-03 1 mL Single Dose Vial 853101 NDC 63323-853-25 Unit of 25 2 mg per mL NDC 63323-853-03 1 mL Single Dose Vial 854101 NDC 63323-854-10 Unit of 25 4 mg per mL NDC 63323-854-03 1 mL Single Dose Vial Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] Hydromorphone Hydrochloride Injection (HPF) is supplied in single dose amber vials. Each single dose vial of sterile aqueous solution contains 10 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. Hydromorphone Hydrochloride Injection (HPF) is preservative free and is supplied as follows: Product Code Unit of Sale Strength Each 851101 NDC 63323-851-10 Unit of 10 10 mg per mL NDC 63323-851-03 1 mL Single Dose Vial 851105 NDC 63323-851-15 Unit of 10 50 mg per 5 mL (10 mg per mL) NDC 63323-851-07 5 mL Single Dose Vial 851150 NDC 63323-851-50 Individually Packaged 500 mg per 50 mL (10 mg per mL) NDC 63323-851-50 50 mL Single Dose Vial PROTECT FROM LIGHT. Protect from light until time of use. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Safety and Handling Instructions Access to drugs with a potential for abuse such as Hydromorphone Hydrochloride Injection and Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by health care providers.
Patient information
Addiction, Abuse, and Misuse Inform patients that the use of Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF), 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 Hydromorphone Hydrochloride Injection or Hydromorphone Hydrochloride Injection (HPF) or when the dosage is increased, and that it can occur even at recommended dosages. 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 (6.2)]. 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 )]. Healthcare professionals can telephone Fresenius Kabi USA, LLC at 1-800-551-7176 for information or to report adverse events on this product. www.fresenius-kabi.com/us 451503E hydro-img-01.jpg
Label text from the FDA structured product label by Fresenius Kabi USA, LLC (revised Jul 15, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydromorphone Hydrochloride in 65 products
Hydromorphone Hydrochloride NDC products (65)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 60687-590 | Hydromorphone Hydrochloride 4 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 60687-579 | Hydromorphone Hydrochloride 2 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 43602-001 | Hydromorphone Hydrochloride 5 mg/5mL Solution | Ascent Pharmaceuticals Inc | ANDA · DEA CII |
| 43602-002 | Hydromorphone Hydrochloride 2 mg/1 Tablet | Ascent Pharmaceuticals Inc | ANDA · DEA CII |
| 43602-004 | Hydromorphone Hydrochloride 8 mg/1 Tablet | Ascent Pharmaceuticals Inc | ANDA · DEA CII |
| 43602-003 | Hydromorphone Hydrochloride 4 mg/1 Tablet | Ascent Pharmaceuticals Inc | ANDA · DEA CII |
| 13107-109 | Hydromorphone Hydrochloride 8 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-108 | Hydromorphone Hydrochloride 4 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-107 | Hydromorphone Hydrochloride 2 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 71335-0723 | Hydromorphone Hydrochloride 4 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 31722-119 | Hydromorphone Hydrochloride 8 mg/1 Tablet, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-122 | Hydromorphone Hydrochloride 32 mg/1 Tablet, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-121 | Hydromorphone Hydrochloride 16 mg/1 Tablet, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-120 | Hydromorphone Hydrochloride 12 mg/1 Tablet, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 0641-6259 | Hydromorphone Hydrochloride .2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6206 | Hydromorphone Hydrochloride .5 mg/.5mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0054-0386 | Hydromorphone Hydrochloride 1 mg/mL Solution | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6170 | Hydromorphone Hydrochloride 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6169 | Hydromorphone Hydrochloride 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0641-6151 | Hydromorphone Hydrochloride 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 0409-2634 | Hydromorphone Hydrochloride 10 mg/mL Injection, Solution | Hospira, Inc. | ANDA · DEA CII |
| 0574-0297 | Hydromorphone Hydrochloride 32 mg/1 Tablet, Extended Release | Padagis US LLC | ANDA · DEA CII |
| 0574-0295 | Hydromorphone Hydrochloride 16 mg/1 Tablet, Extended Release | Padagis US LLC | ANDA · DEA CII |
| 0574-0294 | Hydromorphone Hydrochloride 12 mg/1 Tablet, Extended Release | Padagis US LLC | ANDA · DEA CII |
| 0574-0293 | Hydromorphone Hydrochloride 8 mg/1 Tablet, Extended Release | Padagis US LLC | ANDA · DEA CII |
| 67296-1414 | Hydromorphone Hydrochloride 2 mg/1 Tablet | Redpharm Drug | ANDA · DEA CII |
| 0406-3249 | Hydromorphone Hydrochloride 8 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-3244 | Hydromorphone Hydrochloride 4 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-3243 | Hydromorphone Hydrochloride 2 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0703-0018 | Hydromorphone Hydrochloride 10 mg/mL Injection, Solution | Teva Parenteral Medicines, Inc. | ANDA · DEA CII |
| 0703-0110 | Hydromorphone Hydrochloride 10 mg/mL Injection, Solution | Teva Parenteral Medicines, Inc. | ANDA · DEA CII |
| 0703-0113 | Hydromorphone Hydrochloride 10 mg/mL Injection, Solution | Teva Parenteral Medicines, Inc. | ANDA · DEA CII |
| 13811-704 | Hydromorphone Hydrochloride 32 mg/1 Tablet, Extended Release | Trigen Laboratories, LLC | ANDA · DEA CII |
| 13811-702 | Hydromorphone Hydrochloride 12 mg/1 Tablet, Extended Release | Trigen Laboratories, LLC | ANDA · DEA CII |
| 13811-701 | Hydromorphone Hydrochloride 8 mg/1 Tablet, Extended Release | Trigen Laboratories, LLC | ANDA · DEA CII |
| 13811-703 | Hydromorphone Hydrochloride 16 mg/1 Tablet, Extended Release | Trigen Laboratories, LLC | ANDA · DEA CII |
| 72865-171 | Hydromorphone Hydrochloride 32 mg/1 Tablet, Extended Release | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-170 | Hydromorphone Hydrochloride 16 mg/1 Tablet, Extended Release | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-169 | Hydromorphone Hydrochloride 12 mg/1 Tablet, Extended Release | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-168 | Hydromorphone Hydrochloride 8 mg/1 Tablet, Extended Release | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 63323-851 | Hydromorphone Hydrochloride 10 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 63323-854 | Hydromorphone Hydrochloride 4 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 63323-853 | Hydromorphone Hydrochloride 2 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 63323-852 | Hydromorphone Hydrochloride 1 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA · DEA CII |
| 0641-6254 | Hydromorphone Hydrochloride 2 mg/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | NDA · DEA CII |
| 0409-1805 | Hydromorphone Hydrochloride .25 mg/.5mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-1312 | Hydromorphone Hydrochloride 2 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-3365 | Hydromorphone Hydrochloride 2 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-4264 | Hydromorphone Hydrochloride .5 mg/.5mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-1283 | Hydromorphone Hydrochloride 1 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 0409-1304 | Hydromorphone Hydrochloride 4 mg/mL Injection, Solution | Hospira, Inc. | NDA · DEA CII |
| 60687-566 | Hydromorphone Hydrochloride 5 mg/5mL Solution | American Health Packaging | NDA AUTHORIZED GENERIC · DEA CII |
| 87063-039 | Hydromorphone Hydrochloride 8 mg/1 Tablet | ASCLEMED USA INC. | NDA AUTHORIZED GENERIC · DEA CII |
| 87063-038 | Hydromorphone Hydrochloride 4 mg/1 Tablet | ASCLEMED USA INC. | NDA AUTHORIZED GENERIC · DEA CII |
| 87063-037 | Hydromorphone Hydrochloride 2 mg/1 Tablet | ASCLEMED USA INC. | NDA AUTHORIZED GENERIC · DEA CII |
| 63629-4284 | Hydromorphone Hydrochloride 2 mg/1 Tablet | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC · DEA CII |
| 71335-9701 | Hydromorphone Hydrochloride 4 mg/1 Tablet | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC · DEA CII |
| 42858-303 | Hydromorphone Hydrochloride 8 mg/1 Tablet | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC · DEA CII |
| 42858-302 | Hydromorphone Hydrochloride 4 mg/1 Tablet | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC · DEA CII |
| 42858-301 | Hydromorphone Hydrochloride 2 mg/1 Tablet | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC · DEA CII |
| 42858-304 | Hydromorphone Hydrochloride 5 mg/5mL Solution | Rhodes Pharmaceuticals LLC | NDA AUTHORIZED GENERIC · DEA CII |
| 60760-998 | Hydromorphone Hydrochloride 4 mg/1 Tablet | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC · DEA CII |
| 63629-2532 | Hydromorphone Hydrochloride 3 mg/1 Suppository | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CII |
| 0641-2341 | Hydromorphone Hydrochloride 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | UNAPPROVED DRUG OTHER · DEA CII |
| 0574-7224 | Hydromorphone Hydrochloride 3 mg/1 Suppository | Padagis US LLC | UNAPPROVED DRUG OTHER · DEA CII |
Hydromorphone Hydrochloride recalls
- D-0596-2018 Mar 21, 2018 · Class I · Terminated
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. - D-0597-2018 Mar 21, 2018 · Class I · Terminated
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. - D-1167-2017 Sep 27, 2017 · Class II · Terminated
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. - D-1080-2017 Aug 16, 2017 · Class II · Terminated
Presence of Particulate Matter: Silicone oil - D-1081-2017 Aug 16, 2017 · Class II · Terminated
Presence of Particulate Matter: Silicone oil - D-1082-2017 Aug 16, 2017 · Class II · Terminated
Presence of Particulate Matter: Silicone oil - D-0044-2015 Oct 29, 2014 · Class II · Terminated
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked. - D-020-2013 Oct 31, 2012 · Class I · Terminated
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. - D-1444-2012 Aug 15, 2012 · Class I · Terminated
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Frequently asked questions
What is Hydromorphone Hydrochloride used for?
Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid…
What are the side effects of Hydromorphone Hydrochloride?
The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.2 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )] • Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.4 )] • Neonatal Opioid Withdrawal Syndrome… See the full label for the complete list.
Who makes Hydromorphone Hydrochloride?
Hydromorphone Hydrochloride is listed by 17 labelers in the FDA NDC directory, including American Health Packaging, Ascent Pharmaceuticals Inc, Aurolife Pharma, LLC, Bryant Ranch Prepack.
Has Hydromorphone Hydrochloride been recalled?
The FDA enforcement database lists 9 recalls for Hydromorphone Hydrochloride, most recently D-0596-2018 (class i): Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.