Quick answers
- What is Cefprozil used for?
- The FDA-approved label (Cefprozil, NorthStar Rx LLC, July 9, 2026) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefprozil have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cefprozil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cefprozil been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 26, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Cefprozil?
- 7 companies list prescription products of Cefprozil in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., NorthStar Rx LLC and Rising Pharma Holdings, Inc..
What Cefprozil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil 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. …
— FDA label: Cefprozil, NorthStar Rx LLC, effective July 9, 2026. Read the full label on DailyMed →
The FDA has 13 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 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Powder, for suspension · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 23 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 |
|---|---|---|
| cefprozil 125 mg/5 mL powder, for suspension | Generic | $0.1076–$0.1774 per mL 5 packages, lowest to highest |
| cefprozil 250 mg tablet | Generic | $0.4907 per tablet |
| cefprozil 250 mg tablet, film coated | Generic | $0.4907 per tablet |
| cefprozil 250 mg/5 mL powder, for suspension | Generic | $0.1622–$0.2287 per mL 10 packages, lowest to highest |
| cefprozil 500 mg tablet | Generic | $0.9066 per tablet |
| cefprozil 500 mg tablet, film coated | Generic | $0.9066 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.
- Lupin Pharmaceuticals, Inc.5 products
- NorthStar Rx LLC4 products
- Rising Pharma Holdings, Inc.4 products
- Aurobindo Pharma Limited4 products
- Teva Pharmaceuticals USA, Inc.2 products
- A-S Medication Solutions2 products
- Ascend Laboratories, LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (6)
- ANDA065208Teva · December 6, 2005
- ANDA065276Lupin · December 8, 2005
- ANDA065261Lupin · December 19, 2005
- ANDA065381Aurobindo Pharma · January 30, 2007
- ANDA065340Aurobindo Pharma · May 24, 2007
- ANDA090857Alkem Labs Ltd · April 9, 2024
Shortage status
The FDA drug shortage list does not show these products.
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.
-
March 26, 2021 · Class II · Terminated · D-0332-2021
Superpotent Drug
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only — 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) | 197452, 197453, 309080, 309081 |
|---|---|
| SPL set ID of the quoted label | 8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 |
| FDA labels (SPL) | 13 |
| FDA applications | 6 ANDA |
| Active ingredients (FDA) | CEFPROZIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefprozil, NorthStar Rx LLC, effective July 9, 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 →