Quick answers
- What is Azithromycin used for?
- The FDA-approved label (Zithromax, Pfizer Laboratories Div Pfizer Inc, July 24, 2026) says: “ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Community-acquired pneumonia in adults • Pelvic inflammatory disease in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Azithromycin have a boxed warning?
- The label we quote has no boxed warning, but 1 of 148 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Azithromycin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 9, 2026). Ask your pharmacist about alternatives.
- Has Azithromycin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Azithromycin?
- 53 companies list prescription products of Azithromycin in the FDA NDC Directory, including A-S Medication Solutions, Proficient Rx LP and NuCare Pharmaceuticals, Inc..
What Azithromycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Community-acquired pneumonia in adults • Pelvic inflammatory disease in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections …
— FDA label: Zithromax, Pfizer Laboratories Div Pfizer Inc, effective July 24, 2026. Read the full label on DailyMed →
The FDA has 148 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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.
1 of 148 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| azithromycin dihydrate 100 mg/5 mL powder, for suspension | Generic | $0.3505 per mL |
| azithromycin dihydrate 200 mg/5 mL powder, for suspension | Generic | $0.2033–$0.2905 per mL 9 packages, lowest to highest |
| azithromycin dihydrate 250 mg tablet, film coated | Generic | $0.2708 per tablet |
| azithromycin dihydrate 500 mg tablet, film coated | Generic | $0.5457 per tablet |
| azithromycin dihydrate 600 mg tablet, film coated | Generic | $0.6267 per tablet |
| azithromycin monohydrate 10 mg/mL solution/ drops | Brand: Azasite | $98.39 per mL |
| azithromycin monohydrate 100 mg/5 mL powder, for suspension | Generic | $0.3505 per mL |
| azithromycin monohydrate 200 mg/5 mL powder, for suspension | Generic | $0.2033–$0.2905 per mL 9 packages, lowest to highest |
| azithromycin monohydrate 200 mg/5 mL suspension | Generic | $0.2033 per mL |
| azithromycin monohydrate 250 mg tablet, film coated | Generic | $0.2708 per tablet |
| azithromycin monohydrate 500 mg tablet, film coated | Generic | $0.5457 per tablet |
| azithromycin monohydrate 600 mg tablet, film coated | Generic | $0.6267 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 Solutions21 products
- Proficient Rx LP17 products
- NuCare Pharmaceuticals, Inc.15 products
- Remedyrepack Inc.11 products
- Preferred Pharmaceuticals Inc.9 products
- Pfizer Laboratories Div Pfizer Inc8 products
- Direct_Rx6 products
- Bryant Ranch Prepack5 products
- Redpharm Drug5 products
- Asclemed USA, Inc.5 products
- Teva Pharmaceuticals USA, Inc.5 products
- Sportpharm LLC4 products
- Aurobindo Pharma Limited4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Zydus Lifesciences Limited4 products
- Slate Run Pharmaceuticals, LLC4 products
- Coupler LLC4 products
- Zhejiang Poly Pharm. Co., Ltd.4 products
- Epic Pharma, LLC4 products
- Advanced Rx of Tennessee, LLC3 products
- AvKARE3 products
- Sandoz Inc3 products
- Alembic Pharmaceuticals Limited3 products
- Precision Dose, Inc.3 products
- Lupin Pharmaceuticals, Inc.3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Alembic Pharmaceuticals Inc.3 products
- Bionpharma Inc.3 products
- Puracap Laboratories LLC dba Blu Pharmaceuticals3 products
- Rising Pharma Holdings, Inc.2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Major Pharmaceuticals2 products
- AiPing Pharmaceutical, Inc.2 products
- TAGI Pharma, Inc.2 products
- American Health Packaging2 products
- Lannett Company, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Fresenius Kabi USA, LLC2 products
- Sagent Pharmaceuticals2 products
- State Health Services, Texas Department of2 products
- Chartwell RX, LLC2 products
- Athenex Pharmaceutical Division, LLC.2 products
- AvPAK1 product
- Doc Rx1 product
- Health Department, Oklahoma State1 product
- Slate Run Pharmaceuticals1 product
- Quality Care Products, LLC1 product
- Cardinal Health 107, LLC1 product
- PharmPak, Inc.1 product
- DirectRx1 product
- Eugia US LLC1 product
- Thea Pharma Inc.1 product
- Gland Pharma Limited1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050710 ZITHROMAX | Pfizer | October 19, 1995 | 31, latest July 13, 2026 2026: Labeling · 2021: Labeling · 2019: Labeling |
| NDA050711 ZITHROMAX | Pfizer | July 18, 1996 | 29, latest July 13, 2026 2026: Labeling · 2021: Labeling · 2019: Labeling |
| NDA050733 ZITHROMAX | Pfizer | January 30, 1997 | 28, latest July 13, 2026 2026: Labeling · 2022: Manufacturing (CMC) · 2021: Labeling |
| NDA050784 ZITHROMAX | Pfizer | May 24, 2002 | 19, latest July 13, 2026 2026: Labeling · 2021: Labeling · 2019: Labeling |
| NDA050810 AZASITE | Thea Pharma | April 27, 2007 | 9, latest July 25, 2024 2024: Labeling · 2021: Labeling · 2013: Manufacturing (CMC) |
Generic approvals (33)
- ANDA065209Sandoz · November 14, 2005
- ANDA065211Sandoz · November 14, 2005
- ANDA065212Sandoz · November 14, 2005
- ANDA065218Pliva · November 14, 2005
- ANDA065223Pliva · November 14, 2005
- ANDA065225Pliva · November 14, 2005
- ANDA065179Fresenius Kabi USA · December 13, 2005
- ANDA065246Pliva · July 6, 2006
- ANDA065501Gland Pharma Ltd · November 9, 2009
- ANDA090923Sun Pharm Inds Ltd · April 2, 2013
- ANDA065398Lupin · May 15, 2015
- ANDA065399Lupin · May 15, 2015
- ANDA065400Lupin · May 15, 2015
- ANDA065488Chartwell Rx · May 15, 2015
- ANDA203294Eugia Pharma · June 19, 2015
- ANDA207531Epic Pharma LLC · April 9, 2018
- ANDA207370Aurobindo Pharma Ltd · July 5, 2018
- ANDA207398Aurobindo Pharma Ltd · July 5, 2018
- ANDA211147Zydus Lifesciences · July 31, 2018
- ANDA207566Cspc Ouyi · September 24, 2018
- ANDA203412Hainan Poly · October 9, 2018
- ANDA209201Aurobindo Pharma Ltd · October 9, 2018
- ANDA208249Cspc Ouyi · October 25, 2018
- ANDA209044Sunshine · December 7, 2018
- ANDA209045Sunshine · December 7, 2018
- ANDA209999Bionpharma · December 26, 2018
- ANDA210000Bionpharma · February 26, 2019
- ANDA210001Bionpharma · February 26, 2019
- ANDA208250Cspc Ouyi · April 17, 2019
- ANDA211793Alembic · January 27, 2020
- ANDA211791Alembic · January 28, 2020
- ANDA211792Alembic · January 28, 2020
- ANDA217036Zhejiang Poly Pharm · July 27, 2023
Shortage status
To be discontinued · updated April 9, 2026 · first posted April 9, 2026
| Product | Zithromax, Tablet, 500 mg (NDC 0069-3070-30) |
|---|---|
| Company | Pfizer Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
April 13, 2022 · Class II · Terminated · D-0997-2022
cGMP deviations: Temperature abuse
Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10 — Mckesson Medical-Surgical Inc. Corporate Office
-
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.
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) | 105260, 141963, 204844, 211307, 212446, 226827, 248656, 308459, 308460, 706868 … (+7) |
|---|---|
| SPL set ID of the quoted label | 3b631aa1-2d46-40bc-a614-d698301ea4f9 |
| FDA labels (SPL) | 148 |
| FDA applications | NDA050710, NDA050711, NDA050733, NDA050784, NDA050810, 33 ANDA |
| Active ingredients (FDA) | AZITHROMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zithromax, Pfizer Laboratories Div Pfizer Inc, effective July 24, 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 →