Drug
Who makes azithromycin monohydrate?
7 companies list azithromycin monohydrate as a human prescription drug, including under the names AZASITE. Forms: injection, powder, lyophilized, for solution; solution/ drops; tablet, film coated. Routes: intravenous, ophthalmic, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing azithromycin monohydrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Athenex Pharmaceutical Division, LLC. | injection, powder, lyophilized, for solution | ANDAANDA065501 | 2 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | injection, powder, lyophilized, for solution | ANDAANDA065501 | 1 | 13 |
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA065179 | 1 | 6 |
| GLAND PHARMA LIMITEDIndia | injection, powder, lyophilized, for solution | ANDAANDA065501 | 1 | 4 |
| PharmPak, Inc.United States | tablet, film coated | ANDAANDA065225 | 1 | 1 |
| Thea Pharma, Inc.United States | solution/ drops | NDANDA050810 | 1 | 1 |
| Sagent Pharmaceuticals | injection, powder, lyophilized, for solution | ANDAANDA065501 | 1 | 0 |
Bulk ingredient listings
- Alembic Pharmaceuticals LimitedIndia · 1 NDC
- Calyx Chemicals & Pharmaceuticals LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes azithromycin monohydrate?
- 7 companies list azithromycin monohydrate as a human prescription drug in the openFDA NDC Directory, led by Athenex Pharmaceutical Division, LLC., Sun Pharmaceutical Industries Limited, Fresenius Kabi USA, LLC, GLAND PHARMA LIMITED, PharmPak, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic AZASITE?
- 6 companies list azithromycin monohydrate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies azithromycin monohydrate active ingredient?
- 3 companies list azithromycin monohydrate as a bulk ingredient, including Alembic Pharmaceuticals Limited, Calyx Chemicals & Pharmaceuticals Limited, Jubilant Biosys Limited.