diclofenac sodium
diclofenac sodium is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including arthritis pain reliever, Diclofenac Sodium, Diclofenac sodium. Available dosage forms: gel, tablet, film coated, kit, solution.
Drug Details
- Generic Name
- diclofenac sodium
- Brand Names
- arthritis pain reliever, Diclofenac Sodium, Diclofenac sodium, berkley and jensen arthritis pain, equate arthritis pain, diclofenac sodium, topcare athritis pain reliever, arthritis pain relieving, DICLOFENAC SODIUM, good sense arthritis pain, signature care arthritis pain, DG health arthritis pain, kirkland signature arthritis pain relief, VOLTAREN ARTHRITIS PAIN, Voltaren Arthritis Pain, members mark arthritis pain reliever, equaline arthritis pain relieving, basic care arthritis pain, CareOne arthritis pain relief
- Application Number
- ANDA211253
- Sponsor
- Publix Super Markets 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 )