NDC Code(s) : 62332-487-12
Packager : Alembic Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac sodium Diclofenac sodium SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:62332-487-121 in 1 CARTON 29/11/2022
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 11/29/2022

LABELER - Alembic Pharmaceuticals, Inc.(079288842)

REGISTRANT - Alembic Pharmaceuticals Limited(650574663)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 871411532 MANUFACTURE(62332-487), ANALYSIS(62332-487)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 112 g Bottle and Carton Label

Rx only

NDC 62332-487-12

Diclofenac Sodium Topical Solution, USP 2% w/w

FOR EXTERNAL USE ONLY

Usual dosage:

Apply two pump activations to affected knee(s) two times a day.

Dispense Enclosed Medication Guide to Each Patient

Each pump actuation delivers 1 gram of solution (20 mg diclofenac sodium).

3.8 FL.OZ. (112 grams)

labellabel