Data / Drug companies / Azithromycin dihydrate
Azithromycin dihydrate: 20 companies and 53 products in the FDA NDC directory
Azithromycin dihydrate is listed in the FDA National Drug Code Directory by 20 companies, with 53 products in commercial distribution. 44 of the products (83.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; powder, for suspension; injection, powder, lyophilized, for solution, and the newest product started marketing on October 20, 2025.
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- Companies listing it
- 20
- Products
- 53
- Generic (ANDA) products
- 44 (83.0%)
- Application numbers
- 12
- Routes
- Oral, Intravenous
- Brand names
- Zithromax, Azithromycin
- openFDA record search
- api.fda.gov
Companies that list azithromycin dihydrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | 8 | powder, for suspension; tablet, film coated | New drug applications (NDA) | May 17, 2019 |
| A-S Medication Solutions | 6 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Slate Run Pharmaceuticals, LLC | 5 | powder, for suspension; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 1, 2024 |
| Advanced Rx of Tennessee, LLC | 4 | tablet, film coated; tablet | Generic drugs (ANDA) | August 27, 2024 |
| Coupler LLC | 3 | tablet, film coated; tablet | Generic drugs (ANDA) | October 20, 2025 |
| PD-Rx Pharmaceuticals, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Precision Dose, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Redpharm Drug | 3 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Remedyrepack Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | October 2, 2024 |
| NuCare Pharmaceuticals,Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Preferred Pharmaceuticals Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | January 1, 2025 |
| Proficient Rx LP | 2 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Proficient Rx LP | 2 | tablet, film coated | Generic drugs (ANDA) | July 1, 2019 |
| Asclemed USA, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | July 1, 2019 |
| AvPAK | 1 | tablet, film coated | Generic drugs (ANDA) | December 11, 2020 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Health Department, Oklahoma State | 1 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Quality Care Products, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | August 28, 2024 |
| Sportpharm LLC | 1 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Tagi Pharma, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | July 1, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 40 | 75.5% |
| Powder, for suspension | 7 | 13.2% |
| Injection, powder, lyophilized, for solution | 3 | 5.7% |
| Tablet | 3 | 5.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 44 | 83% |
| New drug applications (NDA) | 9 | 17% |
Pharmacologic classes
| Class | Products |
|---|---|
| Macrolide Antimicrobial | 53 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.