Metronidazole
Tablet · Oral, Topical, Intravenous
Current shortage
Metronidazole, Injection, 500 mg/100 mL (NDC 25021-131-82) – Limited Availability (InfoRLife SA, updated Aug 18, 2026)
Estimated recovery: August 2026; Marketed by Sagent Pharmaceuticals
Metronidazole In Plastic Container, Injection, 500 mg/100 mL (NDC 47335-993-01) – Unavailable (Gland Pharma Limited, updated Jul 22, 2026)
Discontinuation of the manufacture of the drug
Flagyl I.v. Rtu In Plastic Container, Injection, 500 mg/100 mL (NDC 0338-1055-48) – Available (Baxter Healthcare, updated Sep 17, 2026)
Metronidazole in Flexible Container, Injection, 500 mg/100 mL (NDC 0409-0152-24) – Limited Availability (InfoRLife SA, updated Aug 18, 2026)
Labeler: Hospira Inc.
Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection USP and other antibacterial drugs, Metronidazole Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. TREATMENT OF ANAEROBIC INFECTIONS Metronidazole Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection therapy. In a mixed aerobic and anaerobic infection, antibacterial drugs appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection. Metronidazole Injection USP is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol, and penicillin. Intra-Abdominal Infections , including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species in adults and pediatric patients less than 4 months of age. Skin and Skin Structure Infections caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species in adults. Gynecologic Infections , including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, and Peptostreptococcus species in adults. Bacterial Septicemia caused by Bacteroides species including the B. fragilis group and Clostridium species in adults. Bone and Joint Infections , as adjunctive therapy, caused by Bacteroides species including the B. fragilis group in adults. Central Nervous System (CNS) Infections , including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group in adults. Lower Respiratory Tract Infections , including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group in adults. Endocarditis caused by Bacteroides species including the B. fragilis group in adults. PROPHYLAXIS INDICATION The prophylactic administration of Metronidazole Injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in adult patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated. Prophylactic use of Metronidazole Injection should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see DOSAGE AND ADMINISTRATION ). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosage and administration
DOSAGE AND ADMINISTRATION RECOMMENDED DOSAGE FOR THE TREATMENT OF ANAEROBIC BACTERIAL INFECTIONS The recommended dosage schedule for adults for the treatment of anaerobic infections is presented in Table 1: Table 1: Recommended Dosage Schedule for the Treatment of Anaerobic Bacterial Infections in Adults Loading Dose 15 mg/kg infused over one hour (approximately 1 g for a 70-kg adult). Maintenance Dose 7.5 mg/kg infused over one hour every six hours (approximately 500 mg for a 70-kg adult). The first maintenance dose should be instituted six hours following the initiation of the loading dose. Parenteral therapy may be changed to oral metronidazole therapy when conditions warrant, based upon the severity of the disease and the response of the patient to treatment with Metronidazole Injection. The usual adult oral dosage is 7.5 mg/kg every six hours. A maximum of 4 grams should not be exceeded during a 24-hour period. The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment. Recommended Dosage for the Treatment of Intra-Abdominal Infections in Pediatric Patients Less than 4 Months of Age: The recommended dosage schedule for pediatric patients less than 4 months of age for the treatment of intra-abdominal infections is described in Table 2 below. These dosage schedules achieve drug exposures in pediatric patients similar to adults treated with Metronidazole Injection for this indication. Table 2: Recommended Dosage Schedule for the Treatment of Intra-Abdominal Infections in Pediatric Patients Less than 4 months of Age Post-menstrual age (Completed weeks) Loading Dose (mg/kg) Maintenance Dose* (mg/kg) Dosing interval (hours) 23 - < 34 15 7.5 12 34 – 40 15 7.5 8 > 40 – 48 15 7.5 6 *The first maintenance dose is given 24 hours after the start of the loading dose. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levels and toxicity is recommended. 1 In patients receiving Metronidazole Injection in whom gastric secretions are continuously removed by nasogastric aspiration, sufficient metronidazole may be removed in the aspirate to cause a reduction in serum levels. The dose of Metronidazole Injection should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis. Dosage Considerations in Geriatric Patients In elderly patients the pharmacokinetics of metronidazole may be altered and, therefore, monitoring of serum levels may be necessary to adjust the Metronidazole Injection dosage accordingly. RECOMMENDED PROPHYLAXIS DOSAGE For surgical prophylactic use, to prevent postoperative infection in contaminated or potentially contaminated colorectal surgery, the recommended dosage schedule for adults is: 15 mg/kg infused over 30 to 60 minutes and completed approximately one hour before surgery, followed by: 7.5 mg/kg infused over 30 to 60 minutes at 6 and 12 hours after the initial dose. It is important that (1) administration of the initial preoperative dose be completed approximately one hour before surgery so that adequate drug levels are present in the serum and tissues at the time of initial incision, and (2) Metronidazole Injection be administered, if necessary, at 6-hour intervals to maintain effective drug levels. Prophylactic use of Metronidazole Injection should be limited to the day of surgery only, following the above guidelines. IMPORTANT PREPARATION AND ADMINISTRATION INSTRUCTIONS Caution: Metronidazole Injection - is to be administered by slow intravenous drip infusion only, either as a continuous or intermittent infusion. IV admixtures containing metronidazole and other drugs should be avoided. Additives should not be introduced into this solution. If used with a primary intravenous fluid system, the primary solution should be discontinued during metronidazole infusion. DO NOT USE EQUIPMENT CONTAINING ALUMINUM (E.G., NEEDLES, CANNULAE) THAT WOULD COME IN CONTACT WITH THE DRUG SOLUTION. Metronidazole Injection USP is a ready-to-use isotonic solution. NO DILUTION OR BUFFERING IS REQUIRED. Do not refrigerate. Each container of Metronidazole Injection contains 13.5 mEq of sodium. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if cloudy or precipitated or if the seals are not intact. Use sterile equipment. It is recommended that the intravenous administration apparatus be replaced at least once every 24 hours.
Contraindications
Hypersensitivity Metronidazole Injection is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS -Drug Interactions ). Interaction with Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see PRECAUTIONS -Drug Interactions ). Cockayne Syndrome Metronidazole Injection is contraindicated in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome (see ADVERSE REACTIONS ).
Warnings
WARNINGS SEVERE CUTANEOUS ADVERSE REACTIONS: Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazole. Symptoms can be serious and potentially life threatening. If symptoms or signs of SCARs develop, discontinue Metronidazole injection immediately and institute appropriate therapy. CENTRAL AND PERIPHERAL NERVOUS SYSTEM EFFECTS: Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole products. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged oral administration of metronidazole, patients should be observed carefully. The appearance of abnormal neurologic signs demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy.
Precautions
PRECAUTIONS GENERAL: Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Administration of solutions containing sodium ions may result in sodium retention. Care should be taken when administering Metronidazole Injection to patients receiving corticosteroids or to patients predisposed to edema. Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Metronidazole Injection and requires treatment with a candicidal agent. Prescribing Metronidazole Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. INFORMATION FOR PATIENTS: Patients should be counseled that antibacterial drugs including Metronidazole Injection USP should only be used to treat bacterial infections. They do not treat viral infections ( e.g., the common cold). When Metronidazole Injection USP 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 Metronidazole Injection USP or other antibacterial drugs in the future. Advise patients that Metronidazole Injection may increase the risk of serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS). Instruct the patient to be alert for skin rash, blisters, fever or other signs and symptoms of these hypersensitivity reactions. Advise patients to stop Metronidazole injection immediately if they develop any type of rash and seek medical attention. LABORATORY TESTS: Metronidazole is a nitroimidazole, and Metronidazole Injection USP should be used with caution in patients with evidence of or history of blood dyscrasia. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metronidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended before and after therapy. DRUG INTERACTIONS: Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Metronidazole Injection USP is prescribed for patients on this type of anticoagulant therapy. The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported. The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. Alcoholic beverages should not be consumed during metronidazole therapy because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks. QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. DRUG/LABORATORY TEST INTERACTIONS: Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7. symbol CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Tumorigenicity in Rodents: Metronidazole has shown evidence of carcinogenic activity in studies involving chronic, oral administration in mice and rats, but similar studies in the hamster gave negative results. Also, metronidazole has shown mutagenic activity in a number of in vitro assay systems, but studies in mammals (in vivo) failed to demonstrate a potential for genetic damage. PREGNANCY: Teratogenic Effects . Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. Reproduction studies have been performed in rats at doses up to five times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to metronidazole. Metronidazole administered intraperitoneally to pregnant mice at approximately the human dose caused fetotoxicity; administered orally to pregnant mice, no fetotoxicity was observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed (see CONTRAINDICATIONS ). NURSING MOTHERS: Metronidazole is secreted in human milk in concentrations similar to those found in plasma.
Side effects
The following are the most serious adverse reactions reported in patients treated with metronidazole and are also described elsewhere in the labeling: convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy (characterized mainly by numbness or paresthesia of an extremity) (see WARNINGS ). The following adverse reactions associated with the use of metronidazole products were identified in clinical studies or postmarketing reports or published literature. 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. GASTROINTESTINAL: Nausea, anorexia, vomiting, abdominal discomfort, diarrhea, an unpleasant metallic taste, epigastric distress, abdominal cramping, constipation and pancreatitis. MOUTH: A sharp metallic taste. Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy with metronidazole. HEMATOPOIETIC: Reversible neutropenia (leukopenia); thrombocytopenia, eosinophilia. HEPATOBILIARY DISORDERS: Hepatotoxicity and liver failure especially in patients with Cockayne syndrome (see CONTRAINDICATIONS ), jaundice. CARDIOVASCULAR: QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. Flattening of the T-wave may be seen in electrocardiographic tracings. SKIN AND SUBCUTANEOUS DISORDERS: Toxic epidermal necrolysis, Stevens-Johnson syndrome, Fixed drug eruption, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), erythematous rash, bullae, pruritus, swelling face, urticaria, and hyperhidrosis. CENTRAL NERVOUS SYSTEM: Encephalopathy, aseptic meningitis, convulsive seizures, optic neuropathy, peripheral neuropathy (mainly numbness or paresthesia of an extremity), dizziness, vertigo, incoordination, ataxia, confusion, psychosis, dysarthria, irritability, depression, weakness, headache, tinnitus, hearing impairment, hearing loss, and insomnia. LABORATORY INVESTIGATIONS: Hepatic enzymes increased. HYPERSENSITIVITY: Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) (see WARNINGS ), anaphylaxis, angioedema, hypotension, flushing, nasal congestion, and dryness of mouth (or vagina or vulva). RENAL: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, and darkened urine. HEPATIC : Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after initiation of systemic use of metronidazole, have been reported in patients with Cockayne Syndrome (latency from drug start to signs of liver failure as short as 2 days) (see CONTRAINDICATIONS ). LOCAL REACTIONS: Thrombophlebitis after intravenous infusion. This reaction can be minimized or avoided by avoiding prolonged use of indwelling intravenous catheters. OTHER ADVERSE REACTIONS: Fever, hiccup, proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling “serum sickness”. If patients receiving metronidazole drink alcoholic beverages, they may experience abdominal distress, nausea, vomiting, flushing, or headache. A modification of the taste of alcoholic beverages has also been reported. Patients with Crohn’s disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn’s disease is not an approved indication for Metronidazole Injection USP. Darkened Urine: Instances of darkened urine have also been reported, and this manifestation has been the subject of a special investigation. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance.
Drug interactions
DRUG INTERACTIONS: Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Metronidazole Injection USP is prescribed for patients on this type of anticoagulant therapy. The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported. The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. Alcoholic beverages should not be consumed during metronidazole therapy because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks. QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval.
Pregnancy
PREGNANCY: Teratogenic Effects . Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. Reproduction studies have been performed in rats at doses up to five times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to metronidazole. Metronidazole administered intraperitoneally to pregnant mice at approximately the human dose caused fetotoxicity; administered orally to pregnant mice, no fetotoxicity was observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed (see CONTRAINDICATIONS ).
Pediatric use
PEDIATRIC USE: Pediatric Patients Less than 4 Months of Age The safety and effectiveness of Metronidazole Injection have been established for the treatment of intra-abdominal infections in pediatric patients from birth to less than 4 months. Use of Metronidazole Injection in this age group is supported by evidence from data in adults with additional pharmacokinetic and safety data in pediatric patients from birth to less than 4 months of age. A partially randomized, open-label, phase 2/3 study of intravenous Metronidazole Injection in combination with other intravenous antibacterial drugs was conducted in 62 preterm infants (≤ 33 weeks gestational age at birth, and postnatal age <121 days) and 55 late preterm and term infants (≥ 34 weeks gestational age at birth, and postnatal age <121 days), with complicated intra-abdominal infections. The primary objective of this study was to evaluate the safety of metronidazole-containing regimens, which were administered for up to 10 days. The adverse reactions reported in patients receiving metronidazole-containing regimens were comparable to patients receiving other antibacterial regimens in the study and generally similar to adverse reactions described in adults. The safety and effectiveness of Metronidazole Injection in pediatric patients less than 4 months of age have not been established for (1) the treatment of anaerobic infections other than intra-abdominal infections or for (2) prophylaxis of postoperative infections ( see INDICATIONS AND USAGE , CLINICAL PHARMACOLOGY, Pediatric Patients and DOSAGE AND ADMINISTRATION ). Pediatric Patients 4 Months of Age and Older The safety and effectiveness of Metronidazole Injection in pediatric patients 4 months of age and older have not been established.
Overdosage
The use of dosages of metronidazole higher than those recommended has been reported. These include the use of 27 mg/kg three times a day for 20 days, and the use of 75 mg/kg as a single loading dose followed by 7.5 mg/kg maintenance doses. No adverse reactions were reported in either of the two cases. Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia. Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day. TREATMENT: There is no specific antidote for overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.
Description
Metronidazole Injection USP is a sterile, parenteral dosage form of metronidazole in water. Each 100 mL of Metronidazole Injection USP contains a sterile, nonpyrogenic, isotonic, buffered solution of Metronidazole USP 500 mg, Sodium Chloride USP 740 mg, Dibasic Sodium Phosphate
• 7H 2 O USP 112 mg, and Citric Acid Anhydrous USP 40 mg in Water for Injection USP. Metronidazole Injection USP has a calculated osmolarity of 297 mOsmol/liter and a pH of 5.8 (4.5-7.0). Sodium content: 13.5 mEq/container. Metronidazole is classified as a nitroimidazole antimicrobial and is administered by the intravenous route. Metronidazole USP is chemically designated 2-methyl-5-nitroimidazole-1-ethanol (C 6 H 9 N 3 O 3 ): Not made with natural rubber latex, PVC, or DEHP. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests – Plastic Containers. The container/solution unit is a closed system and is not dependent upon entry of external air during administration. No vapor barrier is necessary. Chemical Structure
How supplied
Metronidazole Injection USP, sterile, is supplied in 100 mL fill PAB® containers, each containing an isotonic, buffered solution of 500 mg metronidazole; packaged 24 per case. Metronidazole injection is sterile premixed solution intended for single use only. NDC REF Fill Volume Metronidazole Injection USP 0264-5535-32 D5353-5224 100 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.
Storage
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.
Patient information
INFORMATION FOR PATIENTS: Patients should be counseled that antibacterial drugs including Metronidazole Injection USP should only be used to treat bacterial infections. They do not treat viral infections ( e.g., the common cold). When Metronidazole Injection USP 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 Metronidazole Injection USP or other antibacterial drugs in the future. Advise patients that Metronidazole Injection may increase the risk of serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS). Instruct the patient to be alert for skin rash, blisters, fever or other signs and symptoms of these hypersensitivity reactions. Advise patients to stop Metronidazole injection immediately if they develop any type of rash and seek medical attention.
Label text from the FDA structured product label by B. Braun Medical Inc. (revised Apr 23, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Metronidazole in 161 products
Metronidazole NDC products (161)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7345 | Metronidazole 7.5 mg/g Gel | A-S Medication Solutions | ANDA |
| 50090-0201 | Metronidazole 250 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-0211 | Metronidazole 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-0212 | Metronidazole 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-0213 | Metronidazole 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5691 | Metronidazole 250 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7160 | Metronidazole 7.5 mg/g Gel | A-S Medication Solutions | ANDA |
| 15955-388 | Metronidazole 250 mg/1 Tablet | Alembic Labs LLC | ANDA |
| 15955-389 | Metronidazole 500 mg/1 Tablet | Alembic Labs LLC | ANDA |
| 62332-630 | Metronidazole 10 mg/g Gel | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-018 | Metronidazole 375 mg/1 Capsule | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-017 | Metronidazole 500 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-016 | Metronidazole 250 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-435 | Metronidazole 375 mg/1 Capsule | Alembic Pharmaceuticals Limited | ANDA |
| 46708-630 | Metronidazole 10 mg/g Gel | Alembic Pharmaceuticals Limited | ANDA |
| 46708-021 | Metronidazole 750 mg/1 Tablet, Film Coated, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-429 | Metronidazole 500 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-428 | Metronidazole 250 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 60687-526 | Metronidazole 250 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-550 | Metronidazole 500 mg/1 Tablet | American Health Packaging | ANDA |
| 69292-208 | Metronidazole 500 mg/1 Tablet | AMICI PHARMA INC | ANDA |
| 69292-207 | Metronidazole 250 mg/1 Tablet | AMICI PHARMA INC | ANDA |
| 80830-2465 | Metronidazole 500 mg/100mL Injection, Solution | Amneal Pharmaceuticals Private Limited | ANDA |
| 76420-801 | Metronidazole 500 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-800 | Metronidazole 250 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 59651-813 | Metronidazole 10 mg/g Gel | Aurobindo Pharma Limited | ANDA |
| 59651-770 | Metronidazole 7.5 mg/g Cream | Aurobindo Pharma Limited | ANDA |
| 65862-695 | Metronidazole 500 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-694 | Metronidazole 250 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 50268-534 | Metronidazole 250 mg/1 Tablet | AvPAK | ANDA |
| 50268-535 | Metronidazole 500 mg/1 Tablet | AvPAK | ANDA |
| 68001-364 | Metronidazole 250 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-365 | Metronidazole 500 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 63629-1386 | Metronidazole 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-1388 | Metronidazole 250 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-7916 | Metronidazole 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2468 | Metronidazole 125 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2677 | Metronidazole 250 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2678 | Metronidazole 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0858 | Metronidazole 250 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2949 | Metronidazole 125 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1775 | Metronidazole 250 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1838 | Metronidazole 250 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1922 | Metronidazole 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2640 | Metronidazole 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2681 | Metronidazole 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2259 | Metronidazole 7.5 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 71335-1703 | Metronidazole 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0358 | Metronidazole 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2403 | Metronidazole 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1681 | Metronidazole 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71209-062 | Metronidazole 250 mg/1 Tablet, Film Coated | Cadila Pharmaceuticals Limited | ANDA |
| 71209-063 | Metronidazole 500 mg/1 Tablet, Film Coated | Cadila Pharmaceuticals Limited | ANDA |
| 55154-2343 | Metronidazole 250 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-8190 | Metronidazole 500 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 62135-836 | Metronidazole 375 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 62135-796 | Metronidazole 500 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-795 | Metronidazole 250 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 0713-0574 | Metronidazole 10 mg/g Gel | Cosette Pharmaceuticals, Inc. | ANDA |
| 0713-0637 | Metronidazole 7.5 mg/g Gel | Cosette Pharmaceuticals, Inc. | ANDA |
| 0713-0633 | Metronidazole 7.5 mg/g Cream | Cosette Pharmaceuticals, Inc. | ANDA |
| 0713-0575 | Metronidazole 7.5 mg/g Gel | Cosette Pharmaceuticals, Inc. | ANDA |
| 67046-1060 | Metronidazole 500 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1173 | Metronidazole 500 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 61919-032 | Metronidazole 500 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 21922-070 | Metronidazole 7.5 mg/g Gel | Encube Ethicals, Inc. | ANDA |
| 0168-0383 | Metronidazole 7.5 mg/mL Lotion | Fougera Pharmaceuticals, LLC | ANDA |
| 0168-0323 | Metronidazole 7.5 mg/g Cream | Fougera Pharmaceuticals, LLC | ANDA |
| 68083-373 | Metronidazole 500 mg/100mL Injection, Solution | Gland Pharma Limited | ANDA |
| 68462-184 | Metronidazole 7.5 mg/g Gel | GLENMARK PHARMACEUTICALS INC., USA | ANDA |
| 51407-372 | Metronidazole 500 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-376 | Metronidazole 250 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 0404-9991 | Metronidazole 500 mg/100mL Injection, Solution | Henry Schein, Inc. | ANDA |
| 23155-652 | Metronidazole 500 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-651 | Metronidazole 250 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 0409-0152 | Metronidazole 5 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 85742-025 | Metronidazole 500 mg/1 Tablet, Film Coated | Kanchan Healthcare Inc | ANDA |
| 85742-024 | Metronidazole 250 mg/1 Tablet, Film Coated | Kanchan Healthcare Inc | ANDA |
| 0904-7156 | Metronidazole 250 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7126 | Metronidazole 500 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 58657-739 | Metronidazole 125 mg/1 Tablet | Method Pharmaceuticals LLC | ANDA |
| 58657-939 | Metronidazole 125 mg/1 Tablet | Method Pharmaceuticals LLC | ANDA |
| 58657-934 | Metronidazole 500 mg/1 Tablet | Method Pharmaceuticals LLC | ANDA |
| 58657-933 | Metronidazole 250 mg/1 Tablet | Method Pharmaceuticals LLC | ANDA |
| 16714-557 | Metronidazole 7.5 mg/g Gel | Northstar Rx LLC | ANDA |
| 82868-014 | Metronidazole 500 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-974 | Metronidazole 250 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-441 | Metronidazole 500 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 68071-1876 | Metronidazole 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3039 | Metronidazole 250 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-2251 | Metronidazole 250 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5283 | Metronidazole 250 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5073 | Metronidazole 500 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2409 | Metronidazole 500 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2399 | Metronidazole 500 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2288 | Metronidazole 500 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2280 | Metronidazole 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-719 | Metronidazole 250 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-005 | Metronidazole 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-195 | Metronidazole 250 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-011 | Metronidazole 500 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-007 | Metronidazole 500 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 54348-745 | Metronidazole 250 mg/1 Tablet, Film Coated | PharmPak, Inc. | ANDA |
| 54348-740 | Metronidazole 500 mg/1 Tablet, Film Coated | PharmPak, Inc. | ANDA |
| 68788-8674 | Metronidazole 500 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-6960 | Metronidazole 250 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8552 | Metronidazole 7.5 mg/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7815 | Metronidazole 500 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 63187-035 | Metronidazole 500 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-511 | Metronidazole 250 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-827 | Metronidazole 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 55700-298 | Metronidazole 500 mg/1 Tablet, Film Coated | Quality Care Products LLC | ANDA |
| 67296-2121 | Metronidazole 7.5 mg/g Gel | Redpharm Drug | ANDA |
| 67296-2152 | Metronidazole 500 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 67296-0078 | Metronidazole 500 mg/1 Tablet | Redpharm Drug, inc. | ANDA |
| 70518-3042 | Metronidazole 250 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4495 | Metronidazole 7.5 mg/g Gel | REMEDYREPACK INC. | ANDA |
| 70518-3265 | Metronidazole 500 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3110 | Metronidazole 500 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2663 | Metronidazole 500 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2305 | Metronidazole 500 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1536 | Metronidazole 250 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1241 | Metronidazole 500 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-1240 | Metronidazole 500 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-0088 | Metronidazole 500 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0058 | Metronidazole 500 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0013 | Metronidazole 250 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 16571-664 | Metronidazole 500 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 16571-665 | Metronidazole 250 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 25021-131 | Metronidazole 500 mg/100mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 73473-303 | Metronidazole 7.5 mg/g Gel | Solaris Pharma Corporation | ANDA |
| 85766-024 | Metronidazole 500 mg/1 Tablet | Sportpharm LLC | ANDA |
| 60760-539 | Metronidazole 500 mg/1 Tablet | ST. MARY'S MEDICAL PARK PHARMACY | ANDA |
| 60760-336 | Metronidazole 500 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 47335-993 | Metronidazole 500 mg/100mL Injection, Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4215 | Metronidazole 10 mg/g Gel | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4164 | Metronidazole 10 mg/g Gel | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4116 | Metronidazole 7.5 mg/g Gel | Sun Pharmaceutical Industries, Inc. | ANDA |
| 50111-334 | Metronidazole 500 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-333 | Metronidazole 250 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 29300-227 | Metronidazole 500 mg/1 Tablet, Film Coated | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-226 | Metronidazole 250 mg/1 Tablet, Film Coated | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 72578-007 | Metronidazole 250 mg/1 Tablet | Viona Pharmaceuticals Inc | ANDA |
| 72578-008 | Metronidazole 500 mg/1 Tablet | Viona Pharmaceuticals Inc | ANDA |
| 72578-129 | Metronidazole 7.5 mg/g Cream | Viona Pharmaceuticals Inc | ANDA |
| 72578-209 | Metronidazole 7.5 mg/g Gel | Viona Pharmaceuticals Inc | ANDA |
| 44567-750 | Metronidazole 500 mg/100mL Injection, Solution | WG Critical Care, LLC | ANDA |
| 70771-1046 | Metronidazole 500 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1978 | Metronidazole 7.5 mg/g Gel | Zydus Lifesciences Limited | ANDA |
| 70771-1834 | Metronidazole 7.5 mg/g Cream | Zydus Lifesciences Limited | ANDA |
| 70771-1045 | Metronidazole 250 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 0264-5535 | Metronidazole 500 mg/100mL Solution | B. Braun Medical Inc. | NDA |
| 0338-1055 | Metronidazole 500 mg/100mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 0338-9541 | Metronidazole 500 mg/100mL Injection, Solution | Baxter Healthcare Corporation | NDA |
| 72572-540 | Metronidazole 500 mg/100mL Injection, Solution | Civica, Inc. | NDA |
| 68682-202 | Metronidazole 10 mg/60g Cream | Oceanside Pharmaceuticals | NDA |
| 50090-2126 | Metronidazole 7.5 mg/g Gel | A-S Medication Solutions | NDA AUTHORIZED GENERIC |
| 68308-712 | Metronidazole 7.5 mg/g Lotion | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC |
| 68308-711 | Metronidazole 7.5 mg/g Cream | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC |
| 68308-663 | Metronidazole 10 mg/g Gel | Mayne Pharma Inc. | NDA AUTHORIZED GENERIC |
| 66993-960 | Metronidazole 7.5 mg/g Cream | Prasco Laboratories | NDA AUTHORIZED GENERIC |
Metronidazole recalls
- D-0863-2016 Jun 1, 2016 · Class I · Terminated
Presence of Particulate Matter: identified as a cloth fiber. - D-629-2013 Jul 10, 2013 · Class II · Terminated
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred…
Frequently asked questions
What is Metronidazole used for?
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection USP and other antibacterial drugs, Metronidazole Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting…
What are the side effects of Metronidazole?
The following are the most serious adverse reactions reported in patients treated with metronidazole and are also described elsewhere in the labeling: convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy (characterized mainly by numbness or paresthesia of an extremity) (see WARNINGS ). The following adverse reactions associated with the use of metronidazole… See the full label for the complete list.
Who makes Metronidazole?
Metronidazole is listed by 59 labelers in the FDA NDC directory, including A-S Medication Solutions, Alembic Labs LLC, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited.
Has Metronidazole been recalled?
The FDA enforcement database lists 2 recalls for Metronidazole, most recently D-0863-2016 (class i): Presence of Particulate Matter: identified as a cloth fiber.