Drug
Who makes diclofenac sodium and misoprostol?
10 companies list diclofenac sodium and misoprostol as a human prescription drug, including under the names ARTHROTEC. Forms: tablet, delayed release; tablet, film coated. 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 diclofenac sodium and misoprostol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet, delayed release | ANDAANDA203995, ANDA205143 | 4 | 1 |
| Nivagen Pharmaceuticals LLCUnited States | tablet, delayed release | ANDAANDA205143 | 2 | 2 |
| Actavis LLCUnited States | tablet, delayed release | ANDAANDA201089 | 2 | 1 |
| Amneal Ireland LimitedIreland | tablet, delayed release | ANDAANDA203995 | 2 | 1 |
| Proficient Rx LPUnited States | tablet, delayed release | ANDAANDA205143 | 2 | 1 |
| AvKARE | tablet, delayed release | ANDAANDA201089 | 2 | 0 |
| BluePoint Laboratories Inc. | tablet, delayed release | ANDAANDA201089 | 2 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | NDA AUTHORIZED GENERICNDA020607 | 2 | 0 |
| Pfizer Laboratories Div Pfizer Inc | tablet, film coated | NDANDA020607 | 2 | 0 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, film coated | NDA AUTHORIZED GENERICNDA020607 | 1 | 1 |
Enquiry
Common questions
- Who makes diclofenac sodium and misoprostol?
- 10 companies list diclofenac sodium and misoprostol as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Nivagen Pharmaceuticals LLC, Actavis LLC, Amneal Ireland Limited, Proficient Rx LP. 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 ARTHROTEC?
- 7 companies list diclofenac sodium and 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.