DICLOENAC SODIUM and MISOPROSTOL
DICLOENAC SODIUM and MISOPROSTOL is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including DICLOENAC SODIUM and MISOPROSTOL DR. Available dosage form: tablet.
Drug Details
- Generic Name
- DICLOENAC SODIUM and MISOPROSTOL
- Brand Names
- DICLOENAC SODIUM and MISOPROSTOL DR
- Application Number
- ANDA204355
- Sponsor
- Advanced Rx Pharmacy of Tennessee, LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- DICLOFENAC SODIUM, MISOPROSTOL
Indications and Usage
1. Indications and Usage Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .