NDC Code(s) : 80425-0338-1
Packager : Advanced Rx Pharmacy of Tennessee, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac SodiumDiclofenac Sodium Topical GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0338(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
BENZYL ALCOHOL(UNII: LKG8494WBH)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
WATER(UNII: 059QF0KO0R)
PEG-7 METHYL ETHER(UNII: ENK4Y6S66X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80425-0338-11 in 1 CARTON 19/05/2023
1100 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212351 05/19/2023

LABELER - Advanced Rx Pharmacy of Tennessee, LLC(117023142)

Establishment
Name Address ID/FEI Business Operations
Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0338)

PRINCIPAL DISPLAY PANEL

NDC: 80425-0338-01

Net Wt. 100 g

Rx Only

Diclofenac Sodium Topical Gel, 3%

label 1