Data / Drug companies / Azithromycin monohydrate
Azithromycin monohydrate: 7 companies and 10 products in the FDA NDC directory
Azithromycin monohydrate is listed in the FDA National Drug Code Directory by 7 companies, with 10 products in commercial distribution. 9 of the products (90.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; tablet, film coated; solution/ drops, and the newest product started marketing on August 1, 2025.
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- Companies listing it
- 7
- Products
- 10
- Generic (ANDA) products
- 9 (90.0%)
- Application numbers
- 4
- Routes
- Intravenous, Oral, Ophthalmic
- Brand names
- Azithromycin, Azasite
- openFDA record search
- api.fda.gov
Companies that list azithromycin monohydrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Athenex Pharmaceutical Division, LLC. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | August 30, 2019 |
| Fresenius Kabi USA, LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 20, 2006 |
| Sagent Pharmaceuticals | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | August 1, 2025 |
| Gland Pharma Limited | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 9, 2009 |
| PharmPak, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | July 10, 2019 |
| Sun Pharmaceutical Industries, Inc. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 27, 2023 |
| Thea Pharma Inc. | 1 | solution/ drops | New drug applications (NDA) | November 1, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, powder, lyophilized, for solution | 8 | 80% |
| Tablet, film coated | 1 | 10% |
| Solution/ drops | 1 | 10% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 9 | 90% |
| New drug applications (NDA) | 1 | 10% |
Pharmacologic classes
| Class | Products |
|---|---|
| Macrolide Antimicrobial | 10 |
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.