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Prescription medicine · generic available

Cefixime

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
7Recalls (FDA reports)
6Companies
2004First FDA approval on file

Quick answers

What is Cefixime used for?
The FDA-approved label (Cefixime, Remedyrepack Inc., August 5, 2026) says: “Cefixime 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 Otitis Media Pharyngitis and Tonsillitis Acute Exacerbations of Chronic Bronchitis Uncomplicated Gonorrhea (cervical/urethral) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Cefixime have a boxed warning?
No. None of the 7 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Cefixime?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Cefixime been recalled?
FDA enforcement reports list 7 recalls of products of this medicine; the newest started August 21, 2024 (Class II). A recall usually concerns specific lots, not every product.
Who makes Cefixime?
6 companies list prescription products of Cefixime in the FDA NDC Directory, including Aurobindo Pharma Limited, Lupin Pharmaceuticals, Inc. and Remedyrepack Inc..

What Cefixime is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Cefixime 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 Otitis Media Pharyngitis and Tonsillitis Acute Exacerbations of Chronic Bronchitis Uncomplicated Gonorrhea (cervical/urethral) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of …

— FDA label: Cefixime, Remedyrepack Inc., effective August 5, 2026. Read the full label on DailyMed →

The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 7 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Powder, for suspension · Tablet
RouteOral
Prescription products12 in the FDA NDC Directory

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Cefixime, by strength and form
Strength and formGeneric or brandPharmacies pay
cefixime 100 mg/5 mL
powder, for suspension		 Generic $2.45 per mL
cefixime 200 mg/5 mL
powder, for suspension		 Generic $2.58 per mL
cefixime 400 mg
capsule		 Generic $10.21 per capsule

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA203195
SUPRAX		 Lupin LtdJune 1, 2012 8, latest May 22, 2025
2025: Labeling · 2018: Manufacturing (CMC) · 2018: Labeling

Generic approvals (6)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. August 21, 2024 · Class II · Terminated · D-0648-2024

    Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

    Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 — Lupin Pharmaceuticals Inc.

  2. May 30, 2024 · Class II · Terminated · D-0559-2024

    Failed Content Uniformity Specifications

    Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC — Lupin Pharmaceuticals Inc.

  3. January 3, 2024 · Class II · Terminated · D-0274-2024

    Failed Impurities/Degradation Specifications

    Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 — Lupin Pharmaceuticals Inc.

  4. December 21, 2021 · Class II · Terminated · D-0359-2022

    Failed impurities/degradation specifications

    Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50 — Ascend Laboratories, LLC

  5. November 3, 2021 · Class II · Terminated · D-0229-2022

    Failed Impurities/Degradation Specifications

    Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50 — Ascend Laboratories LLC

  6. April 29, 2021 · Class II · Terminated · D-0390-2021

    Subpotent Drug

    Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, ND — Lupin Pharmaceuticals Inc.

  7. April 15, 2020 · Class II · Terminated · D-1252-2020

    Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

    Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01 — Lupin Pharmaceuticals Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)197451, 309058, 409823, 419849
SPL set ID of the quoted label3194433c-c04e-442b-9668-fbeb0a15bac7
FDA labels (SPL)7
FDA applicationsNDA203195, 6 ANDA
Active ingredients (FDA)CEFIXIME

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Cefixime, Remedyrepack Inc., effective August 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers