Data / Drug companies / Diclofenac sodium and misoprostol
Diclofenac sodium and misoprostol: 11 companies and 21 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Diclofenac sodium and misoprostol is listed in the FDA National Drug Code Directory by 11 companies, with 21 products in commercial distribution. 16 of the products (76.2%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, delayed release; tablet, film coated, and the newest product started marketing on February 23, 2024.
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- Companies listing it
- 11
- Products
- 21
- Generic (ANDA) products
- 16 (76.2%)
- Application numbers
- 4
- Routes
- Oral
- Brand names
- Diclofenac Sodium Misoprostol, Arthrotec
- openFDA record search
- api.fda.gov
Companies that list diclofenac sodium and misoprostol
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Actavis Pharma, Inc. | 2 | tablet, delayed release | Generic drugs (ANDA) | November 1, 2012 |
| Amneal Pharmaceuticals LLC | 2 | tablet, delayed release | Generic drugs (ANDA) | December 1, 2016 |
| AvKARE | 2 | tablet, delayed release | Generic drugs (ANDA) | December 14, 2012 |
| BluePoint Laboratories | 2 | tablet, delayed release | Generic drugs (ANDA) | February 26, 2014 |
| Bryant Ranch Prepack | 2 | tablet, delayed release | Generic drugs (ANDA) | July 15, 2021 |
| Bryant Ranch Prepack | 2 | tablet, delayed release | Generic drugs (ANDA) | July 15, 2021 |
| Mylan Pharmaceuticals Inc. | 2 | tablet, film coated | Authorized generics (NDA) | November 1, 2012 |
| Nivagen Pharmaceuticals, Inc. | 2 | tablet, delayed release | Generic drugs (ANDA) | July 15, 2021 |
| Pfizer Laboratories Div Pfizer Inc | 2 | tablet, film coated | New drug applications (NDA) | December 24, 1997 |
| Proficient Rx LP | 2 | tablet, delayed release | Generic drugs (ANDA) | July 15, 2021 |
| Advanced Rx of Tennessee, LLC | 1 | tablet, film coated | Authorized generics (NDA) | February 23, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, delayed release | 16 | 76.2% |
| Tablet, film coated | 5 | 23.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 16 | 76.2% |
| Authorized generics (NDA) | 3 | 14.3% |
| New drug applications (NDA) | 2 | 9.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nonsteroidal Anti-inflammatory Drug | 21 |
| Prostaglandin E1 Analog | 21 |
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.