misoprostol
misoprostol is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Cytotec. Available dosage form: tablet.
Drug Details
- Generic Name
- misoprostol
- Brand Names
- Cytotec
- Application Number
- NDA019268
- Sponsor
- Pfizer Laboratories Div Pfizer Inc
- NDC Codes
- 2
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- 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) ] . Diclofenac sodium and misoprostol delayed-release tablets are a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of 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. ( 1 )