NDC Code(s) : 45861-066-03
Packager : Pharmaceutica North America, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac SodiumDiclofenac Sodium SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45861-066
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC SODIUM16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYL SULFOXIDE(UNII: YOW8V9698H)
ALCOHOL(UNII: 3K9958V90M)
GLYCERIN(UNII: PDC6A3C0OX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45861-066-032 in 1 CARTON 05/10/2016
1150 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203818 05/10/2016

PRINCIPAL DISPLAY PANEL

Carton Label