Cefixime 400 mg/1
Cefixime · CAPSULE · Aurobindo Pharma Limited
Cefixime is a capsule containing cefixime at 400 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Cefixime
- Generic Name
- Cefixime
- NDC Code (Product)
59651-647- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 400 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA217607
- Marketing Start
- 03/23/2026
Recall History
Lupin Pharmaceuticals Inc.
Failed Content Uniformity Specifications
Ascend Laboratories, LLC
Failed impurities/degradation specifications
Lupin Pharmaceuticals Inc.
Discoloration; Product may not meet specifications for color description once reconstituted.
Lupin Pharmaceuticals Inc.
Subpotent Drug
Lupin Pharmaceuticals Inc.
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Ascend Laboratories LLC
Failed Impurities/Degradation Specifications
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
RemedyRepack Inc.
Failed Impurities/Degradation Specifications
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections (1.1) Otitis Media (1.2) Pharyngitis and Tonsillitis (1.3) Acute Exacerbations of Chronic Bronchitis (1.4) Uncomplicated Gonorrhea (cervical/urethral) (1.5) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime for oral suspension and other antibacterial drugs, cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) 1.1 Uncomplicated Urinary Tract Infections Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis . 1.2 Otitis Media Cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of Haemophilus influenzae , Moraxella catarrhalis…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults: 400 mg daily (2.1) Pediatric patients (6 months and older): 8 mg/kg/day (2.2) 2.1 Adults The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule and tablet may be administered without regard to food. In the treatment of infections due to Streptococcus pyogenes , a therapeutic dosage of cefixime should be administered for at least 10 days. 2.2 Pediatric Patients (6 months or older) The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours. Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because cefixime for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL). Table 1. Suggested doses for pediatric patients * T…
Contraindications
4 CONTRAINDICATIONS Cefixime for oral suspension is contraindicated in patients with known allergy to cefixime or other cephalosporins. Contraindicated in patients with known allergy to cefixime or other cephalosporins. (4)
Drug Interactions
7 DRUG INTERACTIONS Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. (7.1) Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants. (7.2) 7.1 Carbamazepine Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations. 7.2 Warfarin and Anticoagulants Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly. 7.3 Drug/Laboratory Test Interactions A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide. The administration of cefixime may result in a false-positive reaction for glucose in the urine using Clinitest ®** , Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix ®** or TesTape ®** ) be used. A false-positive dir…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting. (6) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/m edwatch. 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. The most commonly seen adverse reactions in U.S. trials of the tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric p…
Frequently Asked Questions
What is Cefixime used for?
Cefixime contains Cefixime. It is a capsule taken oral. Consult your doctor for specific uses.
Is Cefixime a controlled substance?
Cefixime is not classified as a controlled substance by the DEA.
What is the generic name for Cefixime?
The generic name for Cefixime is Cefixime. There are 7 other brand versions of Cefixime.
What is the NDC code for Cefixime 400 mg/1?
The NDC (National Drug Code) for Cefixime 400 mg/1 is 59651-647, listed by Aurobindo Pharma Limited.