Drug
Who makes azithromycin dihydrate?
22 companies list azithromycin dihydrate as a human prescription drug, including under the names Zithromax. Forms: injection, powder, lyophilized, for solution; powder, for suspension; tablet; tablet, film coated. Routes: intravenous, 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 dihydrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | injection, powder, lyophilized, for solution; powder, for suspension; tablet, film coated | NDANDA050710, NDA050711, NDA050733 | 8 | 0 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA208249, ANDA208250 | 6 | 3 |
| Slate Run Pharmaceuticals, LLCUnited States | injection, powder, lyophilized, for solution; powder, for suspension | ANDAANDA203412, ANDA217036 | 5 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA208249, ANDA208250 | 4 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA207566, ANDA208249, ANDA208250 | 4 | 1 |
| Coupler LLCUnited States | tablet; tablet, film coated | ANDAANDA065400, ANDA208249, ANDA208250 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA208249, ANDA208250 | 3 | 1 |
| Precision Dose Inc.United States | tablet, film coated | ANDAANDA207566, ANDA208249, ANDA208250 | 3 | 1 |
| RedPharm DrugUnited States | tablet, film coated | ANDA, NDAANDA208249, ANDA208250, NDA050711 | 3 | 1 |
| Advanced Rx of Tennessee, LLC | tablet; tablet, film coated | ANDAANDA065398, ANDA065399, ANDA208249 | 3 | 0 |
| ACI Healthcare USA, Inc.United States | tablet, film coated | ANDAANDA215772, ANDA215773 | 2 | 2 |
| Direct RxUnited States | tablet, film coated | ANDAANDA208249, ANDA208250 | 2 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA208249, ANDA208250 | 2 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA208249, ANDA208250 | 2 | 1 |
| TAGI Pharma, Inc. | tablet, film coated | ANDAANDA208249, ANDA208250 | 2 | 0 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, film coated | ANDAANDA208250 | 1 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet, film coated | ANDAANDA208250 | 1 | 1 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA208249 | 1 | 1 |
| Health Department, Oklahoma StateUnited States | tablet, film coated | ANDAANDA208249 | 1 | 1 |
| AvPAK | tablet, film coated | ANDAANDA208250 | 1 | 0 |
| Quality Care Products, LLC | tablet, film coated | ANDAANDA208250 | 1 | 0 |
| Sportpharm LLC | tablet, film coated | ANDAANDA208249 | 1 | 0 |
Bulk ingredient listings
- Anuh Pharma Ltd.India · 1 NDC
- Calyx Chemicals & Pharmaceuticals LimitedIndia · 1 NDC
- HEC Pharm USA Inc.China · 1 NDC
- Jiangsu Weiqida Pharmaceutical Co., Ltd.China · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Pfizer IncUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- TAPI Croatia industries d.o.o.Croatia · 1 NDC
- Viatris Inc.India · 1 NDC
Enquiry
Common questions
- Who makes azithromycin dihydrate?
- 22 companies list azithromycin dihydrate as a human prescription drug in the openFDA NDC Directory, led by Pfizer Laboratories Div Pfizer Inc, International Medication Systems, Ltd., Slate Run Pharmaceuticals, LLC, Proficient Rx LP, RemedyRepack, 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 Zithromax?
- 21 companies list azithromycin dihydrate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies azithromycin dihydrate active ingredient?
- 10 companies list azithromycin dihydrate as a bulk ingredient, including Anuh Pharma Ltd., Calyx Chemicals & Pharmaceuticals Limited, HEC Pharm USA Inc., Jiangsu Weiqida Pharmaceutical Co., Ltd..