diclofenac potassium

FDA Drug Profile — Diclofenac Potassium, diclofenac potassium, Cambia, Diclofenac potassium, ZIPSOR

diclofenac potassium is listed in the FDA National Drug Code directory with 36 NDC codes, marketed under brand names including Diclofenac Potassium, diclofenac potassium, Cambia. Available dosage forms: tablet, coated, tablet, film coated, capsule, liquid filled, powder, for solution.

Drug Details

Generic Name
diclofenac potassium
Brand Names
Diclofenac Potassium, diclofenac potassium, Cambia, Diclofenac potassium, ZIPSOR
Application Number
ANDA075229
Sponsor
Northwind Health Company, LLC
NDC Codes
36
Dosage Forms
TABLET, COATED, TABLET, FILM COATED, CAPSULE, LIQUID FILLED, POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients
DICLOFENAC POTASSIUM

Indications and Usage

1 INDICATIONS AND USAGE Diclofenac Potassium is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: Diclofenac Potassium is not indicated for the prophylactic therapy of migraine. The safety and effectiveness of Diclofenac Potassium have not been established for cluster headache, which is present in an older, predominantly male population. Diclofenac Potassium is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older ( 1 ) Limitations of Use ( 1 ): Diclofenac Potassium is not indicated for the prophylactic therapy of migraine Safety and effectiveness of Diclofenac Potassium not established for cluster headache, which is present in an older, predominantly male population