Vancomycin Hydrochloride
Injection, Powder, Lyophilized, For Solution · Intravenous, Oral, Intravitreal
Uses
Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of: Clostridioides difficile -associated diarrhea ( 1.6 ) Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) ( 1.7 ) Limitations of Use ( 1.8 ) Vancomycin Hydrochloride for Injection administered intravenously is not approved for the treatment of C. difficile -associated diarrhea and enterocolitis caused by susceptible isolates of Staphylococcus aureus because it is not effective. Vancomycin Hydrochloride for Injection administered orally is not approved for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections because it is not effective. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.9 ) 1.1 Septicemia Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of septicemia due to: Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.2 Infective Endocarditis Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of infective endocarditis due to: Susceptible isolates of MRSA. Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use Vancomycin Hydrochloride for Injection in combination with an aminoglycoside. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside. 1.3 Skin and Skin Structure Infections Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of skin and skin structure infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.4 Bone Infections Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of bone infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.5 Lower Respiratory Tract Infections Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of lower respiratory tract infections due to: Susceptible isolates of MRSA Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.6 Clostridioides difficile -Associated Diarrhea Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of C. difficile -associated diarrhea (CDAD) in adult and pediatric patients less than 18 years of age. 1.7 Enterocolitis Caused by S. aureus (including methicillin-resistant strains) Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of enterocolitis caused by susceptible isolates of Staphylococcus aureus in adults and pediatric patients less than 18 years of age. 1.8 Limitations of Use Vancomycin Hydrochloride for Injection administered intravenously is not approved for the treatment of the following conditions because it is not effective: C.
Dosage and administration
See full prescribing information for important information on intravenous and oral administration, preparation and storage instructions ( 2.1 , 2.5 , 2.8 ). Recommended Dosage and Administration Intravenous Use: Administer Vancomycin Hydrochloride for Injection in a diluted solution by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions. Adult Patients: 2 grams (g) divided either as 0.5 g every 6 hours or 1 g every 12 hours ( 2.2 ) Pediatric Patients (1 month and older): 10 mg/kg per dose given every 6 hours ( 2.2 ) Pediatric Patients (younger than 1 month of age): See full prescribing information for recommended dosage ( 2.2 ) Patients with Renal Impairment: See full prescribing information for recommended dosage in patients with renal impairment ( 2.4 ) Oral use: Adult Patients (18 years of age or greater): C. difficile -Associated Diarrhea: 125 mg administered orally 4 times daily for 10 days ( 2.3 ). Staphylococcal enterocolitis: 500 mg to 2 grams administered orally in 3 or 4 divided doses for 7 to 10 days ( 2.3 ) Pediatric Patients (less than 18 years of age): For both C. difficile -associated diarrhea and staphylococcal enterocolitis: 40 mg/kg in 3 or 4 divided doses for 7 days to 10 days. The total daily dosage should not exceed 2 g ( 2.3 ) 2.1 Important Administration Instructions for Intravenous Use To reduce the risk of infusion related adverse reactions, administer diluted Vancomycin Hydrochloride for Injection by intravenous infusion over 60 minutes or greater [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 )] . Diluted Vancomycin Hydrochloride for Injection concentrations of no more than 5 mg/mL are recommended in adults [see Dosage and Administration ( 2.2 )]. See also age-specific recommendations [see Dosage and Administration ( 2.2 , 2.3 )] . In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used. Infusion related events may occur, however, at any rate or concentration [see Warnings and Precautions ( 5.5 )]. Other drugs should not be added to the diluted Vancomycin Hydrochloride for Injection [see Dosage and Administration ( 2.7 )] . Administer diluted Vancomycin Hydrochloride for Injection prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions ( 5.5 )]. Administer diluted Vancomycin Hydrochloride for Injection by a secure intravenous route of administration to avoid local irritation and phlebitis reactions [see Warnings and Precautions ( 5.6 )] . 2.2 Intravenous Dosage in Adult and Pediatric Patients with Normal Renal Function Dosage in Adult Patients The usual daily intravenous dose is 2 grams (g) divided either as 500 mg every 6 hours or 1 g every 12 hours. Administer each dose by intravenous infusion over a period of 60 minutes or greater. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. Dosage in Pediatric Patients Aged 1 Month and Older The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients. Dosage in Pediatric Patients Younger than 1 Month of Age In pediatric patients, up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for pediatric patients in the 1 st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients. 2.3 Orally Administered Dosage in Adult and Pediatric Patients Dosage in Adult Patients C. difficile -associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 days to 10 days. Dosage in Pediatric Patients (Less than 18 years of age) For both C. difficile -associated diarrhea and staphylococcal enterocolitis, the usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 days to 10 days. The total daily dosage should not exceed 2 g. 2.4 Intravenous Dosage in Patients with Renal Impairment Dosage adjustment must be made in adult and pediatric patients with renal impairment. The initial dose should be no less than 15 mg/kg, in adult patients with any degree of renal impairment. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measure trough vancomycin serum concentrations to guide therapy, especially in seriously ill patients with changing renal function. For functionally anephric patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentration. A dose of 1.9 mg/kg/24 hr should be given after the initial dose of 15 mg/kg. 2.5 Directions for the Preparation, Dilution, and Storage of the Single-Dose Vials for Intravenous Use Preparation Vancomycin Hydrochloride for Injection must be reconstituted and further diluted . No preservative is present in this product. Aseptic technique must be used in the preparation of final IV solution. Reconstitution of the Spray-dried Powder : At the time of use, reconstitute the vials of Vancomycin Hydrochloride for Injection with Sterile Water for Injection to a concentration of 50 mg of vancomycin/mL (see following table for volume of diluent).
Dosage forms and strengths
Vancomycin Hydrochloride for Injection is a sterile white, almost white to tan to brown, spray-dried powder in single-dose vials each containing vancomycin hydrochloride equivalent to 500 mg, 750 mg, 1 gram, 1.25 grams or 1.5 grams vancomycin base. Vancomycin Hydrochloride for Injection is a sterile spray-dried powder for injection in single-dose vials containing vancomycin hydrochloride equivalent to 500 mg, 750 mg, 1 gram, 1.25 grams or 1.5 grams of vancomycin base ( 3 )
Contraindications
Vancomycin Hydrochloride for Injection is contraindicated in patients with known hypersensitivity to vancomycin and polysorbate 80. Hypersensitivity to vancomycin, and polysorbate 80 ( 4 )
Warnings and precautions
Nephrotoxicity : Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. Monitor serum vancomycin concentrations and renal function in patients receiving Vancomycin Hydrochloride for Injection intravenously. Monitor renal function in patients over 65 years of age receiving Vancomycin Hydrochloride for Injection orally. ( 5.1 ) Ototoxicity : Ototoxicity has occurred in patients administered vancomycin intravenously or orally. Monitor for signs and symptoms of ototoxicity during oral or intravenous therapy. Assessment of auditory function may be appropriate in some instances. ( 5.2 ) Severe Dermatologic Reactions : Discontinue Vancomycin Hydrochloride for Injection at the first appearance of skin rashes, mucosal lesions, or blisters ( 5.3 ). Neutropenia : This has been reported in patients administered vancomycin intravenously or orally. Periodically monitor leukocyte count. ( 5.4 ) Infusion Reactions : Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular, chest pain and vancomycin infusion reaction which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Hydrochloride for Injection in a diluted solution over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. ( 2.1 , 5.5 ) Phlebitis : To reduce the risk of local irritation and phlebitis, administer Vancomycin Hydrochloride for Injection by a secure intravenous route of administration. ( 5.6 ) Clostridioides difficile- Associated Diarrhea : Evaluate patients if diarrhea occurs. ( 5.7 ) Development of Drug-Resistant Bacteria : Prescribing Vancomycin Hydrochloride for Injection in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. ( 5.9 ) 5.1 Nephrotoxicity Vancomycin Hydrochloride for Injection administered intravenously or orally can result in acute kidney injury (AKI), including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. AKI is manifested by increasing blood urea nitrogen (BUN) and serum creatinine (Cr). The risk of AKI increases with higher vancomycin serum levels, prolonged exposure, concomitant administration of other nephrotoxic drugs, concomitant administration of piperacillin-tazobactam [see Drug Interactions ( 7.2 )] , volume depletion, pre-existing renal impairment and in critically ill patients and patients with co-morbid conditions that predispose to renal impairment. Monitor serum vancomycin concentrations and renal function in all patients receiving Vancomycin Hydrochloride for Injection intravenously. Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatine increased) has occurred following oral vancomycin hydrochloride capsule therapy in randomized controlled clinical studies and can occur either during or after completion of therapy. The risk of nephrotoxicity is increased in patients >65 years of age [see Adverse Reactions ( 6.1 ) and Use in Specific Populations ( 8.5 )] . In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with oral Vancomycin Hydrochloride for Injection therapy to detect potential vancomycin induced nephrotoxicity. More frequent monitoring is recommended in patients with comorbidities that predispose to impairment in renal function or are concomitantly receiving other nephrotoxic drugs, in critically ill patients, in patients with changing renal function, and in patients requiring higher therapeutic vancomycin levels. If acute kidney injury occurs, discontinue Vancomycin Hydrochloride for Injection or reduce the dose. 5.2 Ototoxicity Ototoxicity has occurred in patients administered vancomycin intravenously or orally. It may be transient or permanent. Ototoxicity manifests as tinnitus, hearing loss, dizziness or vertigo. The risk is higher in older patients, patients who are receiving higher doses, who have an underlying hearing loss, who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside or who have underlying renal impairment. Monitor for signs and symptoms of ototoxicity during oral or intravenous therapy with Vancomycin Hydrochloride for Injection. Discontinue Vancomycin Hydrochloride for Injection if ototoxicity occurs. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity. 5.3 Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue Vancomycin Hydrochloride for Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. 5.4 Neutropenia Reversible neutropenia has been reported in patients administered vancomycin intravenously or orally. Patients who will undergo prolonged therapy with Vancomycin Hydrochloride for Injection or those who are receiving concomitant drugs which may cause neutropenia should have periodic monitoring of the leukocyte count. 5.5 Infusion Reactions Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain may occur with rapid Vancomycin Hydrochloride for Injection intravenous administration.
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrotoxicity [see Warnings and Precautions ( 5.1 )] Ototoxicity [see Warnings and Precautions ( 5.2 )] Severe Dermatologic Reactions [see Warnings and Precautions ( 5.3 )] Neutropenia [see Warnings and Precautions ( 5.4 )] Infusion Reactions [see Warnings and Precautions ( 5.5 )] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.7 )] The common adverse reactions following intravenously, and orally administered vancomycin were acute kidney injury, hearing loss, neutropenia, anaphylaxis, vancomycin infusion reaction. ( 6.1 ) The most common adverse reactions of orally administered vancomycin (> 10%) were nausea, abdominal pain, and hypokalemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Patients Receiving Intravenously and Orally Administered Vancomycin The following adverse reactions associated with the use of intravenously and orally administered vancomycin were identified in clinical trials: Renal and urinary disorders: Acute kidney injury and interstitial nephritis [see Warnings and Precautions ( 5.1 )] Ear and labyrinth disorders: Tinnitus, hearing loss, vertigo [see Warnings and Precautions ( 5.2 )] Skin and subcutaneous tissue disorders: Erythema (especially of the face, neck and upper torso) and pruritus which are manifestations of rashes including exfoliative dermatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), Linear IgA bullous dermatosis (LABD) [see Warnings and Precautions ( 5.3 )] . Blood and lymphatic system disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia [see Warnings and Precautions ( 5.4 )] Immune system disorders: Hypersensitivity reactions including anaphylaxis and vancomycin infusion reaction [see Warnings and Precautions ( 5.5 )] General disorders and administration site conditions: General discomfort, fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration. Vancomycin Hydrochloride for Injection is not approved for intramuscular and intraperitoneal administration [see Warnings and Precautions ( 5.6 )] Gastrointestinal disorders: Pseudomembranous colitis [see Warnings and Precautions ( 5.7 )] Cardiac disorders: Cardiac arrest, chest pain Laboratory abnormalities: Elevated blood urea nitrogen, elevated serum creatinine Musculoskeletal and connective tissue disorders: Muscle pain Nervous system disorders: Dizziness Respiratory, thoracic and mediastinal disorders: Wheezing, dyspnea Vascular disorders: Hypotension, shock, vasculitis Adverse Reactions in Patients Receiving Oral Administration of Vancomycin Hydrochloride Capsules The data described below reflect exposure to vancomycin hydrochloride capsules in 260 adult subjects in two Phase 3 clinical trials for the treatment of diarrhea associated with C. difficile . In both trials, subjects received vancomycin hydrochloride capsules 125 mg orally four times daily. The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%) and 52% were male. Adverse reactions occurring in ≥5% of vancomycin hydrochloride capsules-treated subjects are shown in Table 2 . The most common adverse reactions associated with vancomycin hydrochloride capsules (≥10%) were nausea, abdominal pain, and hypokalemia. Table 2: Common (≥5%) Adverse Reactions a for Vancomycin Hydrochloride Capsules Reported in Clinical Trials for Treatment of Diarrhea Associated with C. difficile a Adverse reaction rates were derived from the incidence of treatment-emergent adverse events. System/Organ Class Adverse Reaction Vancomycin Hydrochloride Capsule % (N=260) Gastrointestinal disorders Nausea Abdominal pain Vomiting Diarrhea Flatulence 17 15 9 9 8 General disorders and administration site conditions Pyrexia Edema peripheral Fatigue 9 6 5 Infections and infestations Urinary tract infection 8 Metabolism and nutrition disorders Hypokalemia 13 Musculoskeletal and connective tissue disorders Back pain 6 Nervous system disorders Headache 7 Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with vancomycin hydrochloride capsules. Nephrotoxicity following vancomycin hydrochloride capsules typically first occurred within one week after completion of treatment (median day of onset was Day 16). Nephrotoxicity following vancomycin hydrochloride capsules occurred in 6% of subjects >65 years of age and 3% of subjects ≤65 years of age. The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects >65 years of age than in subjects ≤65 years of age. Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride capsules. The most common adverse events leading to discontinuation of vancomycin hydrochloride capsules were C. difficile colitis (<1%), nausea (<1%), and vomiting (<1%). 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of vancomycin (administered orally and intravenously).
Drug interactions
Anesthetic Agents : Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. ( 2.1 , 7.1 ) Piperacillin/Tazobactam : Increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients ( 7.2 ) 7.1 Anesthetic Agents Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.4 )] . 7.2 Piperacillin-Tazobactam Studies have detected an increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients receiving concomitant piperacillin/tazobactam and Vancomycin Hydrochloride for Injection. No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin. 7.3 Ototoxic and/or Nephrotoxic Drugs Concurrent and/or sequential systemic or topical use of other potentially, neurotoxic and/or nephrotoxic drugs requires more frequent monitoring of renal function.
Use in specific populations
8.1 Pregnancy Risk Summary There are no available data on vancomycin use in pregnant women to inform a drug associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes (see Data ) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data ) . Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see Clinical Pharmacology ( 12.3 )] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) 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. Data Human Data A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin for suspected or documented methicillin-resistant Staphylococcus-aureus (MRSA) infections in the second or third trimester. The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin intravenously at the time of delivery. Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits 1 . No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). There were no oral embryo-fetal toxicity studies conducted in animals with this Vancomycin Injection product. 8.2 Lactation Risk Summary Vancomycin is present in human milk following intravenous administration, however, there are insufficient data to inform the levels. There are no available data on vancomycin presence in milk following oral administration. Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see Clinical Pharmacology ( 12.3 )] . There are no data on the effects of vancomycin on the breastfed infant or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Vancomycin Hydrochloride for Injection and any potential adverse effects on the breastfed infant from Vancomycin Hydrochloride for Injection or from the underlying maternal condition. 8.4 Pediatric Use Vancomycin Hydrochloride for Injection administered intravenously is indicated in pediatric patients less than 18 years of age for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections [see Indications and Usage ( 1.1 to 1.5 ) and Dosage and Administration ( 2.2 )] . Vancomycin Hydrochloride for Injection administered orally is indicated in pediatric patients less than 18 years of age for the treatment of Clostridioides difficile -associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) [see Indications and Usage ( 1.6 , 1.7 ) and Dosage and Administration ( 2.3 )] . In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin Hydrochloride for Injection intravenously [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . More severe infusion related reactions related to Vancomycin Hydrochloride for Injection administration may occur in pediatric patients. Concomitant administration of vancomycin and intravenous anesthetic agents has been associated with erythema and histamine-like flushing in all patients including pediatric patients [see Warnings and Precautions ( 5.5 )] . 8.5 Geriatric Use Clinical studies with another vancomycin hydrochloride drug product in C. difficile -associated diarrhea have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on vancomycin use in pregnant women to inform a drug associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes (see Data ) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data ) . Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see Clinical Pharmacology ( 12.3 )] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) 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. Data Human Data A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin for suspected or documented methicillin-resistant Staphylococcus-aureus (MRSA) infections in the second or third trimester. The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin intravenously at the time of delivery. Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits 1 . No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). There were no oral embryo-fetal toxicity studies conducted in animals with this Vancomycin Injection product.
Pediatric use
8.4 Pediatric Use Vancomycin Hydrochloride for Injection administered intravenously is indicated in pediatric patients less than 18 years of age for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections [see Indications and Usage ( 1.1 to 1.5 ) and Dosage and Administration ( 2.2 )] . Vancomycin Hydrochloride for Injection administered orally is indicated in pediatric patients less than 18 years of age for the treatment of Clostridioides difficile -associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) [see Indications and Usage ( 1.6 , 1.7 ) and Dosage and Administration ( 2.3 )] . In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin Hydrochloride for Injection intravenously [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . More severe infusion related reactions related to Vancomycin Hydrochloride for Injection administration may occur in pediatric patients. Concomitant administration of vancomycin and intravenous anesthetic agents has been associated with erythema and histamine-like flushing in all patients including pediatric patients [see Warnings and Precautions ( 5.5 )] .
Geriatric use
8.5 Geriatric Use Clinical studies with another vancomycin hydrochloride drug product in C. difficile -associated diarrhea have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy. In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with Vancomycin Hydrochloride for Injection to detect potential vancomycin induced nephrotoxicity [see Warnings and Precautions ( 5.1 )] and Adverse Reactions ( 6.1 )] . Patients over 65 years of age may take longer to respond to therapy compared to patients 65 years of age and younger. Clinicians should be aware of the importance of appropriate duration of Vancomycin Hydrochloride for Injection treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely. Vancomycin Hydrochloride for Injection 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 [see Dosage and Administration ( 2.4 )] , and it may be useful to monitor renal function [see Warnings and Precautions ( 5.1 )] .
Overdosage
Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance. For current information on the management of overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .
Description
Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis ). The chemical name for vancomycin hydrochloride is ( S a)-(3 S ,6 R ,7 R ,22 R ,23 S , 26 S ,36 R ,38a R )-44-[[2- O -(3-Amino-2,3,6-trideoxy-3- C -methyl-α-L- lyxo -hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R )-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H ,16 H -[1,6,9]oxadiazacyclohexadecino[4,5- m ][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66 H 75 Cl 2 N 9 O 24
• HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula: Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 gram, 1.25 grams or 1.5 grams vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 gram vial contains 1 gram vancomycin (equivalent to 1.025 grams vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 gram vial contains 1.25 grams vancomycin (equivalent to 1.28 grams vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 gram vial contains 1.5 grams vancomycin (equivalent to 1.54 grams vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration ( 2.5 , 2.8 )]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration ( 2.8 )] . Figure
Mechanism of action
12.1 Mechanism of Action Vancomycin is an antibacterial drug [see Microbiology ( 12.4 )] .
How supplied
How Supplied Vancomycin Hydrochloride for Injection is a white, almost white to tan to brown, sterile spray-dried powder in single-dose flip-top vials each containing vancomycin hydrochloride equivalent to 750 mg, 1.25 grams or 1.5 grams of vancomycin base, supplied as follows: NDC Vancomycin Hydrochloride for Injection Package Factor 83634-114-20 750 mg Single-Dose Vial 10 vials per carton 83634-115-30 1.25 gram Single-Dose Vial 10 vials per carton 83634-116-30 1.5 gram Single-Dose Vial 10 vials per carton Storage Conditions Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) is permitted [See USP Controlled Room Temperature]. Storage after reconstitution and dilution is described elsewhere in the labeling [see Dosage and Administration ( 2.5 , 2.8 )] . Discard unused portion. Sterile, Preservative-free. The container closure is not made with natural rubber latex.
Storage
Storage Conditions Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) is permitted [See USP Controlled Room Temperature]. Storage after reconstitution and dilution is described elsewhere in the labeling [see Dosage and Administration ( 2.5 , 2.8 )] . Discard unused portion. Sterile, Preservative-free. The container closure is not made with natural rubber latex.
Patient information
Acute Kidney Injury Advise patients that Vancomycin Hydrochloride for Injection can result in kidney damage and that blood tests are required to monitor vancomycin blood levels and kidney function during therapy [see Warnings and Precautions ( 5.1 )] . Hearing Loss or Balance Problems Advise patients that Vancomycin Hydrochloride for Injection may result in decreased hearing and to report hearing loss or balance problems to their health care provider [see Warnings and Precautions ( 5.2 )] . Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Hydrochloride for Injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters [see Warnings and Precautions ( 5.3 )] . Infusion Reactions During or After Intravenous Use Advise patients that generalized skin redness, skin rash, itching, flushing, muscle pain, chest pain, shortness of breath, wheezing, or dizziness may occur during Vancomycin Hydrochloride for Injection infusion [see Warnings and Precautions ( 5.5 )] . Diarrhea Diarrhea is a common problem caused by antibacterial drugs, including vancomycin, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs during treatment with Vancomycin Hydrochloride for Injection, patients should contact their physician as soon as possible [see Warnings and Precautions ( 5.7 )] . Antibacterial Resistance Patients should be counseled that antibacterial drugs including Vancomycin Hydrochloride for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin Hydrochloride for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Vancomycin Hydrochloride for Injection or other antibacterial drugs in the future. AVENACY Mfd. for Avenacy Schaumburg, IL 60173 (USA) Made in China ©2026 Avenacy April 2026
Label text from the FDA structured product label by Avenacy, LLC (revised Jul 31, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Vancomycin Hydrochloride in 122 products
- Vancomycin in 1 product
Vancomycin Hydrochloride NDC products (127)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69238-2261 | Vancomycin Hydrochloride 250 mg/5mL Solution | Amneal Pharmaceuticals NY LLC | ANDA |
| 62559-830 | Vancomycin Hydrochloride 250 mg/5mL Powder, For Solution | ANI Pharmaceuticals, Inc. | ANDA |
| 67877-750 | Kit | Ascend Laboratories, LLC | ANDA |
| 67877-751 | Kit | Ascend Laboratories, LLC | ANDA |
| 59651-669 | Kit | Aurobindo Pharma Limited | ANDA |
| 59651-670 | Kit | Aurobindo Pharma Limited | ANDA |
| 68001-407 | Vancomycin Hydrochloride 10 g/1 Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 68001-406 | Vancomycin Hydrochloride 5 g/1 Injection, Powder, Lyophilized, For Solution | BluePoint Laboratories | ANDA |
| 72162-2305 | Vancomycin Hydrochloride 125 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 72162-2306 | Vancomycin Hydrochloride 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-1972 | Vancomycin Hydrochloride 250 mg/5mL Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 63629-1971 | Vancomycin Hydrochloride 250 mg/5mL Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 72162-1775 | Vancomycin Hydrochloride 250 mg/5mL Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 71335-2950 | Vancomycin Hydrochloride 250 mg/5mL Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 71335-2948 | Vancomycin Hydrochloride 250 mg/5mL Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 63629-1970 | Vancomycin Hydrochloride 250 mg/5mL Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 31722-211 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-210 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Camber Pharmaceuticals, Inc. | ANDA |
| 42494-450 | Vancomycin Hydrochloride 125 mg/1 Capsule | Cameron Pharmaceuticals | ANDA |
| 42494-451 | Vancomycin Hydrochloride 250 mg/1 Capsule | Cameron Pharmaceuticals | ANDA |
| 72572-207 | Vancomycin Hydrochloride 500 mg/5mL Injection, Powder, Lyophilized, For Solution | Civica, Inc | ANDA |
| 72572-029 | Vancomycin Hydrochloride 1 g/1 Injection, Powder, Lyophilized, For Solution | Civica, Inc | ANDA |
| 72572-105 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Civica, Inc | ANDA |
| 55150-203 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Eugia US LLC | ANDA |
| 55150-204 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Eugia US LLC | ANDA |
| 55150-472 | Vancomycin Hydrochloride 1.5 g/30mL Injection, Powder, Lyophilized, For Solution | Eugia US LLC | ANDA |
| 55150-471 | Vancomycin Hydrochloride 1.25 g/25mL Injection, Powder, Lyophilized, For Solution | Eugia US LLC | ANDA |
| 55150-206 | Vancomycin Hydrochloride 10 g/1 Injection, Powder, Lyophilized, For Solution | Eugia US LLC | ANDA |
| 55150-205 | Vancomycin Hydrochloride 5 g/1 Injection, Powder, Lyophilized, For Solution | Eugia US LLC | ANDA |
| 43538-805 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Eurofarma, Inc. | ANDA |
| 43538-810 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Eurofarma, Inc. | ANDA |
| 63323-284 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 63323-203 | Vancomycin Hydrochloride 750 mg/15mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 63323-314 | Vancomycin Hydrochloride 10 g/100mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 63323-221 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 63323-295 | Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 68083-569 | Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68083-144 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68083-143 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68083-570 | Vancomycin Hydrochloride 10 g/100mL Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68083-595 | Vancomycin Hydrochloride 750 mg/1 Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68083-597 | Vancomycin Hydrochloride 1.5 g/1 Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68083-596 | Vancomycin Hydrochloride 1.25 g/1 Injection, Powder, Lyophilized, For Solution | Gland Pharma Limited | ANDA |
| 68462-477 | Vancomycin Hydrochloride 750 mg/1 Injection, Powder, Lyophilized, For Solution | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 68462-478 | Vancomycin Hydrochloride 1.25 g/1 Injection, Powder, Lyophilized, For Solution | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 68462-479 | Vancomycin Hydrochloride 1.5 g/1 Injection, Powder, Lyophilized, For Solution | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 68462-956 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 68462-955 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 0404-9965 | Vancomycin Hydrochloride 500 mg/1 Injection, Powder, Lyophilized, For Solution | Henry Schein, Inc. | ANDA |
| 23155-858 | Vancomycin Hydrochloride 125 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-859 | Vancomycin Hydrochloride 250 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-968 | Vancomycin Hydrochloride 250 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-967 | Vancomycin Hydrochloride 125 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 0143-9152 | Vancomycin Hydrochloride 1.25 g/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9153 | Vancomycin Hydrochloride 1.5 g/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9355 | Vancomycin 750 mg/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9356 | Vancomycin Hydrochloride 500 mg/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9357 | Vancomycin Hydrochloride 1 g/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9359 | Vancomycin Hydrochloride 10 g/1 Injection, Powder, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9358 | Vancomycin Hydrochloride 5 g/1 Injection, Powder, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0409-6509 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Hospira, Inc. | ANDA |
| 0409-4332 | Vancomycin Hydrochloride 500 mg/1 Injection, Powder, Lyophilized, For Solution | Hospira, Inc. | ANDA |
| 0409-3515 | Vancomycin Hydrochloride 1.5 g/1 Injection, Powder, Lyophilized, For Solution | Hospira, Inc. | ANDA |
| 0409-1319 | Vancomycin Hydrochloride 500 mg/5mL Injection, Powder, Lyophilized, For Solution | Hospira, Inc. | ANDA |
| 0409-6531 | Vancomycin Hydrochloride 750 mg/1 Injection, Powder, Lyophilized, For Solution | Hospira, Inc. | ANDA |
| 0409-6533 | Vancomycin Hydrochloride 1 g/1 Injection, Powder, Lyophilized, For Solution | Hospira, Inc. | ANDA |
| 71288-023 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-026 | Vancomycin Hydrochloride 10 g/95mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-025 | Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-024 | Vancomycin Hydrochloride 750 mg/15mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-022 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Meitheal Pharmaceuticals Inc. | ANDA |
| 67457-342 | Vancomycin Hydrochloride 10 g/100mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | ANDA |
| 67457-341 | Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | ANDA |
| 67457-340 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | ANDA |
| 67457-339 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | ANDA |
| 0121-1033 | Vancomycin Hydrochloride 250 mg/1 Capsule | PAI Holdings, LLC dba PAI Pharma | ANDA |
| 0121-1032 | Vancomycin Hydrochloride 125 mg/1 Capsule | PAI Holdings, LLC dba PAI Pharma | ANDA |
| 87188-203 | Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution | Plano Pharmaceuticals Inc. | ANDA |
| 87188-202 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Plano Pharmaceuticals Inc. | ANDA |
| 67296-2290 | Vancomycin Hydrochloride 125 mg/1 Capsule | Redpharm Drug | ANDA |
| 25021-147 | Vancomycin Hydrochloride 750 mg/15mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-148 | Vancomycin Hydrochloride 1.25 g/25mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-149 | Vancomycin Hydrochloride 1.5 g/30mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-151 | Vancomycin Hydrochloride 1 g/20mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 25021-150 | Vancomycin Hydrochloride 500 mg/10mL Injection, Powder, Lyophilized, For Solution | Sagent Pharmaceuticals | ANDA |
| 66288-7100 | Vancomycin Hydrochloride 100 g/1 Injection, Powder, Lyophilized, For Solution | SAMSON MEDICAL TECHNOLOGIES LLC | ANDA |
| 70436-020 | Vancomycin Hydrochloride 500 mg/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-021 | Vancomycin Hydrochloride 1 g/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-022 | Vancomycin Hydrochloride 5 g/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 70436-023 | Vancomycin Hydrochloride 10 g/1 Injection, Powder, Lyophilized, For Solution | Slate Run Pharmaceuticals, LLC | ANDA |
| 82449-005 | Vancomycin Hydrochloride 750 mg/20mL Injection, Powder, Lyophilized, For Solution | STERISCIENCE SPECIALTIES PRIVATE LIMITED | ANDA |
| 82449-006 | Vancomycin Hydrochloride 1.25 g/30mL Injection, Powder, Lyophilized, For Solution | STERISCIENCE SPECIALTIES PRIVATE LIMITED | ANDA |
| 82449-007 | Vancomycin Hydrochloride 1.5 g/30mL Injection, Powder, Lyophilized, For Solution | STERISCIENCE SPECIALTIES PRIVATE LIMITED | ANDA |
| 64380-729 | Vancomycin Hydrochloride 125 mg/1 Capsule | Strides Pharma Science Limited | ANDA |
| 64380-730 | Vancomycin Hydrochloride 250 mg/1 Capsule | Strides Pharma Science Limited | ANDA |
| 70594-122 | Vancomycin Hydrochloride 500 mg/1 Injection, Powder, Lyophilized, For Solution | Xellia Pharmaceuticals USA LLC | ANDA |
| 70594-123 | Vancomycin Hydrochloride 1 g/1 Injection, Powder, Lyophilized, For Solution | Xellia Pharmaceuticals USA LLC | ANDA |
| 39822-0470 | Vancomycin Hydrochloride 1.5 g/1 Injection, Powder, Lyophilized, For Solution | XGen Pharmaceuticals DJB, Inc. | ANDA |
| 39822-0460 | Vancomycin Hydrochloride 1.25 g/1 Injection, Powder, Lyophilized, For Solution | XGen Pharmaceuticals DJB, Inc. | ANDA |
| 83634-116 | Vancomycin Hydrochloride 1.5 g/1 Injection, Powder, For Solution | Avenacy, LLC | NDA |
| 83634-114 | Vancomycin Hydrochloride 750 mg/1 Injection, Powder, For Solution | Avenacy, LLC | NDA |
| 83634-115 | Vancomycin Hydrochloride 1.25 g/1 Injection, Powder, For Solution | Avenacy, LLC | NDA |
| 0338-3582 | Vancomycin Hydrochloride 750 mg/150mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-3581 | Vancomycin Hydrochloride 500 mg/100mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-0122 | Vancomycin Hydrochloride 1.25 g/250mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-0124 | Vancomycin Hydrochloride 1.5 g/300mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-3551 | Vancomycin Hydrochloride 500 mg/100mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-3552 | Vancomycin Hydrochloride 1 g/200mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-3580 | Vancomycin Hydrochloride 750 mg/150mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-3583 | Vancomycin Hydrochloride 1 g/200mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0143-9161 | Vancomycin Hydrochloride 513 mg/mg Injection, Powder, For Solution | HIKMA PHARMACEUTICALS USA INC. | NDA |
| 0143-9162 | Vancomycin Hydrochloride 1025 mg/mg Injection, Powder, For Solution | HIKMA PHARMACEUTICALS USA INC. | NDA |
| 0143-9473 | Vancomycin Hydrochloride 769 mg/mg Injection, Powder, For Solution | HIKMA PHARMACEUTICALS USA INC. | NDA |
| 0143-9163 | Vancomycin Hydrochloride 5.13 g/g Injection, Powder, For Solution | HIKMA PHARMACEUTICALS USA INC. | NDA |
| 0143-9164 | Vancomycin Hydrochloride 10.25 g/g Injection, Powder, For Solution | HIKMA PHARMACEUTICALS USA INC. | NDA |
| 0143-9474 | Vancomycin Hydrochloride 1280 mg/mg Injection, Powder, For Solution | HIKMA PHARMACEUTICALS USA INC. | NDA |
| 0143-9475 | Vancomycin Hydrochloride 1540 mg/mg Injection, Powder, For Solution | HIKMA PHARMACEUTICALS USA INC. | NDA |
| 72078-066 | Vancomycin Hydrochloride 2 g/40mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | NDA |
| 72078-065 | Vancomycin Hydrochloride 1.75 g/35mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | NDA |
| 67457-705 | Vancomycin Hydrochloride 750 mg/15mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | NDA |
| 67457-824 | Vancomycin Hydrochloride 1.5 g/30mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | NDA |
| 67457-823 | Vancomycin Hydrochloride 1.25 g/25mL Injection, Powder, Lyophilized, For Solution | Mylan Institutional LLC | NDA |
| 71467-014 | Vancomycin Hydrochloride 10.25 g/g Injection, Powder, For Solution | Zhejiang Novus Pharma Co., Ltd. | NDA |
| 80425-0514 | Vancomycin Hydrochloride 250 mg/1 Capsule | Advanced Rx of Tennessee, LLC | NDA AUTHORIZED GENERIC |
| 62559-390 | Vancomycin Hydrochloride 125 mg/1 Capsule | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC |
| 62559-391 | Vancomycin Hydrochloride 250 mg/1 Capsule | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC |
| 67296-2143 | Vancomycin Hydrochloride 125 mg/1 Capsule | Redpharm Drug | NDA AUTHORIZED GENERIC |
Vancomycin Hydrochloride recalls
- D-0805-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0820-2026 Sep 9, 2026 · Class II · Ongoing
CGMP Deviations - D-0442-2024 Apr 24, 2024 · Class I · Terminated
Superpotent Drug: Due to overfilling of drug powder - D-0184-2023 Feb 1, 2023 · Class I · Terminated
Presence of Particulate Matter: Glass particulate matter detected in injectable. - D-0574-2020 Dec 18, 2019 · Class II · Terminated
Discoloration: Product complaints of discoloration after reconstitution of vials. - D-0123-2018 Dec 27, 2017 · Class I · Terminated
Presence of Particulate Matter: glass particulate found in vial - D-0387-2015 Feb 25, 2015 · Class II · Terminated
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. - D-0390-2015 Feb 25, 2015 · Class II · Terminated
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. - D-0254-2015 Nov 26, 2014 · Class III · Terminated
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Frequently asked questions
What is Vancomycin Hydrochloride used for?
Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract…
What are the side effects of Vancomycin Hydrochloride?
The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrotoxicity [see Warnings and Precautions ( 5.1 )] Ototoxicity [see Warnings and Precautions ( 5.2 )] Severe Dermatologic Reactions [see Warnings and Precautions ( 5.3 )] Neutropenia [see Warnings and Precautions ( 5.4 )] Infusion Reactions [see Warnings and Precautions ( 5.5 )] Clostridioides… See the full label for the complete list.
Who makes Vancomycin Hydrochloride?
Vancomycin Hydrochloride is listed by 35 labelers in the FDA NDC directory, including Amneal Pharmaceuticals NY LLC, ANI Pharmaceuticals, Inc., Ascend Laboratories, LLC, Aurobindo Pharma Limited.
Has Vancomycin Hydrochloride been recalled?
The FDA enforcement database lists 9 recalls for Vancomycin Hydrochloride, most recently D-0805-2026 (class ii): CGMP Deviations