Data / Drug companies / Misoprostol
Misoprostol: 15 companies and 25 products in the FDA NDC directory
Misoprostol is listed in the FDA National Drug Code Directory by 15 companies, with 25 products in commercial distribution. 19 of the products (76.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, and the newest product started marketing on December 10, 2024.
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- Companies listing it
- 15
- Products
- 25
- Generic (ANDA) products
- 19 (76.0%)
- Application numbers
- 4
- Routes
- Oral
- Brand names
- Cytotec
- openFDA record search
- api.fda.gov
Companies that list misoprostol
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| GenBioPro, Inc. | 3 | tablet | Generic drugs (ANDA) | September 30, 2024 |
| American Health Packaging | 2 | tablet | Generic drugs (ANDA) | April 1, 2023 |
| Ani Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | April 11, 2022 |
| Bryant Ranch Prepack | 2 | tablet | Authorized generics (NDA) | April 11, 2022 |
| Lupin Pharmaceuticals,Inc. | 2 | tablet | Generic drugs (ANDA) | July 25, 2012 |
| Mylan Pharmaceuticals Inc. | 2 | tablet | Authorized generics (NDA) | December 27, 2009 |
| Novel Laboratories, Inc. | 2 | tablet | Generic drugs (ANDA) | July 25, 2012 |
| NuCare Pharmaceuticals,Inc. | 2 | tablet | Generic drugs (ANDA) | April 11, 2022 |
| Pfizer Laboratories Div Pfizer Inc | 2 | tablet | New drug applications (NDA) | December 27, 1986 |
| AvPAK | 1 | tablet | Generic drugs (ANDA) | October 3, 2024 |
| Cardinal Health 107, LLC | 1 | tablet | Generic drugs (ANDA) | December 10, 2024 |
| PD-Rx Pharmaceuticals, Inc. | 1 | tablet | Generic drugs (ANDA) | April 11, 2022 |
| PharmPak, Inc. | 1 | tablet | Generic drugs (ANDA) | July 10, 2019 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | April 11, 2022 |
| Redpharm Drug | 1 | tablet | Authorized generics (NDA) | December 27, 2009 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 25 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 19 | 76% |
| Authorized generics (NDA) | 4 | 16% |
| New drug applications (NDA) | 2 | 8% |
Pharmacologic classes
| Class | Products |
|---|---|
| Prostaglandin E1 Analog | 25 |
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.