NDC Code(s) : 72189-473-01
Packager : Direct_Rx

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac Sodium GelDiclofenac Sodium Gel GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72189-473(NDC:62332-581)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC SODIUM30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
POLYETHYLENE GLYCOL MONOMETHYL ETHER 350(UNII: ENK4Y6S66X)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72189-473-011 g in 1 TUBE Type 0: Not a Combination Product19/05/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212351 05/19/2023

LABELER - Direct_Rx(079254320)

REGISTRANT - Direct_Rx(079254320)

Establishment
Name Address ID/FEI Business Operations
Direct_Rx 079254320 relabel(72189-473)

PRINCIPAL DISPLAY PANEL

72189-473-01