Quick answers
- What is Cefuroxime axetil used for?
- The FDA-approved label (Cefuroxime Axetil, Remedyrepack Inc., August 5, 2026) says: “Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) Acute bacterial otitis media (pediatric patients) Acute bacterial maxillary sinusitis (adults and pediatric patients) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefuroxime axetil have a boxed warning?
- No. None of the 31 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cefuroxime axetil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cefuroxime axetil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cefuroxime axetil?
- 16 companies list prescription products of Cefuroxime axetil in the FDA NDC Directory, including A-S Medication Solutions, PD-Rx Pharmaceuticals, Inc. and NuCare Pharmaceuticals, Inc..
What Cefuroxime axetil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) Acute bacterial otitis media (pediatric patients) Acute bacterial maxillary sinusitis (adults and pediatric patients) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and …
— FDA label: Cefuroxime Axetil, Remedyrepack Inc., effective August 5, 2026. Read the full label on DailyMed →
The FDA has 31 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 31 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 41 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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cefuroxime axetil 250 mg tablet | Generic | $0.2741 per tablet |
| cefuroxime axetil 250 mg tablet, film coated | Generic | $0.2741 per tablet |
| cefuroxime axetil 500 mg tablet | Generic | $0.3448 per tablet |
| cefuroxime axetil 500 mg tablet, film coated | Generic | $0.3448 per tablet |
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.
- A-S Medication Solutions10 products
- PD-Rx Pharmaceuticals, Inc.4 products
- NuCare Pharmaceuticals, Inc.4 products
- Redpharm Drug3 products
- Aurobindo Pharma Limited3 products
- Ascend Laboratories, LLC2 products
- Rising Pharma Holdings, Inc.2 products
- NorthStar Rx LLC2 products
- American Health Packaging2 products
- Coupler LLC2 products
- Golden State Medical Supply, Inc.2 products
- Remedyrepack Inc.1 product
- Advanced Rx of Tennessee, LLC1 product
- Preferred Pharmaceuticals Inc.1 product
- Major Pharmaceuticals1 product
- Proficient Rx LP1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA065308Aurobindo Pharma · March 29, 2006
- ANDA065496Alkem Labs Ltd · June 7, 2010
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 309095, 309097, 309098 |
|---|---|
| SPL set ID of the quoted label | 76cec54f-d167-4298-951b-5411a3c47f4a |
| FDA labels (SPL) | 31 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | CEFUROXIME AXETIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefuroxime Axetil, Remedyrepack Inc., effective August 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →