diclofenac sodium

FDA Drug Profile — arthritis pain relieving, Diclofenac sodium, good sense arthritis pain, DICLOFENAC SODIUM, Voltaren Arthritis Pain

diclofenac sodium is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including arthritis pain relieving, Diclofenac sodium, good sense arthritis pain. Available dosage forms: gel, tablet, film coated, kit, solution.

Drug Details

Generic Name
diclofenac sodium
Brand Names
arthritis pain relieving, Diclofenac sodium, good sense arthritis pain, DICLOFENAC SODIUM, Voltaren Arthritis Pain, berkley and jensen arthritis pain, equate arthritis pain, arthritis pain reliever, Diclofenac Sodium, diclofenac sodium, equaline arthritis pain relieving, basic care arthritis pain, topcare athritis pain reliever, signature care arthritis pain, DG health arthritis pain, kirkland signature arthritis pain relief, VOLTAREN ARTHRITIS PAIN, up and up arthritis pain reliever, members mark arthritis pain reliever
Application Number
ANDA211253
Sponsor
Meijer Distribution Inc
NDC Codes
50
Dosage Forms
GEL, TABLET, FILM COATED, KIT, SOLUTION
Routes
TOPICAL, ORAL
Active Ingredients
DICLOFENAC SODIUM

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 )