NDC Code(s) : 62332-581-31
Packager : Alembic Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac Sodium Diclofenac Sodium Topical GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:62332-581-311 in 1 CARTON 15/09/2022
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 09/15/2022

LABELER - Alembic Pharmaceuticals Inc.(079288842)

REGISTRANT - Alembic Pharmaceuticals Limited(650574663)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 871411532 MANUFACTURE(62332-581), ANALYSIS(62332-581)

PRINCIPAL DISPLAY PANEL

NDC 62332-581-31

Net Wt. 100 g

Rx Only

Diclofenac Sodium Topical Gel, 3%

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