NDC Code(s) : 80425-0337-1
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 SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0337(NDC:62332-487)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC SODIUM20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
DIMETHYL SULFOXIDE(UNII: YOW8V9698H)
HYDROXYPROPYL CELLULOSE (430000 WAMW)(UNII: VQ8ZWO78F6)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80425-0337-11 in 1 CARTON 19/05/2023
1112 g in 1 BOTTLE, PUMP Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212506 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(80425-0337)

PRINCIPAL DISPLAY PANEL

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