Quick answers
- What is Zithromax?
- Zithromax is a brand name of Azithromycin, a prescription medicine. The FDA NDC Directory lists 9 Zithromax products in 4 strengths and forms.
- Who makes Zithromax?
- Pfizer holds the FDA application for Zithromax (NDA050710, approved October 19, 1995). 1 other company (repackagers or distributors) also list Zithromax products.
- Is there a generic or store brand of Zithromax?
- Yes. The FDA NDC Directory lists 129 other products with the same active ingredients, strength and form as a Zithromax product, 129 of them generic. Ask your pharmacist whether one is right for you.
- Has Zithromax been recalled?
- FDA enforcement reports list 1 recall of Zithromax products; the newest started January 2, 2014. A recall usually concerns specific lots, not every product.
What Zithromax is
Each Zithromax product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Azithromycin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| azithromycin dihydrate 200 mg/5 mL powder, for suspension (oral) | Zithromax | 21 products, 11 companies | DailyMed |
| azithromycin dihydrate 250 mg tablet, film coated (oral) | Zithromax | 54 products, 30 companies | DailyMed |
| azithromycin dihydrate 500 mg tablet, film coated (oral) | Zithromax | 53 products, 26 companies | DailyMed |
| azithromycin dihydrate 500 mg/5 mL injection, powder, lyophilized, for solution (intravenous) | Zithromax | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Azithromycin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Zithromax
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Zithromax products.
- Pfizer Laboratories Div Pfizer Inc8 products
- Redpharm Drug1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 2, 2014 · Class III · Terminated · D-745-2014
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-8 — Pfizer Inc.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.