NDC Code(s) : 62332-549-15, 62332-549-45, 62332-549-46
Packager : Alembic Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ADAPALENEADAPALENE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-549
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADAPALENE(UNII: 1L4806J2QF)
(ADAPALENE - UNII:1L4806J2QF) 		ADAPALENE3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
EDETATE DISODIUM(UNII: 7FLD91C86K)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLOXAMER 124(UNII: 1S66E28KXA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-549-151 in 1 CARTON 22/06/2020
115 g in 1 TUBE Type 0: Not a Combination Product
2NDC:62332-549-451 in 1 CARTON 22/06/2020
245 g in 1 TUBE Type 0: Not a Combination Product
3NDC:62332-549-461 in 1 CARTON 22/06/2020
345 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 ANDA213508 06/22/2020

LABELER - Alembic Pharmaceuticals Inc.(079288842)

REGISTRANT - Alembic Pharmaceuticals Limited(650574663)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 871411532 MANUFACTURE(62332-549), ANALYSIS(62332-549)

PRINCIPAL DISPLAY PANEL

45 g pump45 g pump

Rx only

NDC 62332-549-46

Adapalene Gel USP, 0.3%

PUMP

FOR TOPICAL USE ONLY

NET WT.45 g

Alembic

For topical use only. Not for ophthalmic, oral, or intravaginal use.

Usual dosage: apply a thin film once a day at nighttime to affected areas. See package insert for complete prescribing information.

Each gram contains: adapalene USP, 0.3% (3 mg) in an aqueous gel consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment.

Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Protect from freezing.

For lot number and expiration date see below the crimp of Pump.

Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

45 g pump45 g pump

Rx only

NDC 62332-549-45

Adapalene Gel USP, 0.3%

TUBE

FOR TOPICAL USE ONLY

NET WT.45 g

Alembic

For topical use only. Not for ophthalmic, oral, or intravaginal use.

Usual dosage: apply a thin film once a day at nighttime to affected areas. See package insert for complete prescribing information.

Each gram contains: adapalene USP, 0.3% (3 mg) in an aqueous gel consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment.

Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Protect from freezing.

For lot number and expiration date, see on crimp of tube.

Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA