diclofenac

FDA Drug Profile — Xiclo

diclofenac is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Xiclo. Available dosage forms: capsule, patch.

Drug Details

Generic Name
diclofenac
Brand Names
Xiclo
Application Number
Sponsor
Catalent Pharma Solutions, LLC
NDC Codes
3
Dosage Forms
CAPSULE, PATCH
Routes
TRANSDERMAL
Active Ingredients
DICLOFENAC

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 )