Drug
Who makes misoprostol?
15 companies list misoprostol as a human prescription drug, including under the names Cytotec. Forms: tablet. Routes: 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 misoprostol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| GenBioPro, Inc. | tablet | ANDAANDA076095, ANDA210201 | 3 | 0 |
| Lupin LimitedIndia | tablet | ANDAANDA091667 | 2 | 14 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA076095 | 2 | 5 |
| ANI Pharmaceuticals, Inc.United States | tablet | ANDAANDA076095 | 2 | 1 |
| Bryant Ranch PrepackUnited States | tablet | ANDA, NDA AUTHORIZED GENERICANDA076095, NDA019268 | 2 | 1 |
| Novel Laboratories IncUnited States | tablet | ANDAANDA091667 | 2 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA076095, ANDA091667 | 2 | 1 |
| Mylan Pharmaceuticals, Inc. | tablet | NDA AUTHORIZED GENERICNDA019268 | 2 | 0 |
| Pfizer Laboratories Div Pfizer Inc | tablet | NDANDA019268 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA076095 | 1 | 34 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA076095 | 1 | 1 |
| PharmPak, Inc.United States | tablet | ANDAANDA091667 | 1 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA076095 | 1 | 1 |
| RedPharm DrugUnited States | tablet | NDA AUTHORIZED GENERICNDA019268 | 1 | 1 |
| AvPAK | tablet | ANDAANDA210201 | 1 | 0 |
Bulk ingredient listings
- Chirogate International Inc.Taiwan · 1 NDC
- Everlight Chemical Industrial Corporation Kuanyin II Plant · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Piramal Healthcare (Canada) LimitedIndia · 1 NDC
- YS Life Science Co., Ltd.South Korea · 1 NDC
Enquiry
Common questions
- Who makes misoprostol?
- 15 companies list misoprostol as a human prescription drug in the openFDA NDC Directory, led by GenBioPro, Inc., Lupin Limited, Pharma Packaging Solutions, LLC dba Tjoapack, LLC, ANI Pharmaceuticals, Inc., Bryant Ranch Prepack. 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 Cytotec?
- 12 companies list misoprostol 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 misoprostol active ingredient?
- 6 companies list misoprostol as a bulk ingredient, including Chirogate International Inc., Everlight Chemical Industrial Corporation Kuanyin II Plant, Kalchem International Inc., MEDISCA Inc..