NDC Code(s) : 62332-630-45, 62332-630-60, 62332-630-55
Packager : Alembic Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metronidazole Metronidazole GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-630
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE(UNII: 140QMO216E)
(METRONIDAZOLE - UNII:140QMO216E) 		METRONIDAZOLE10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BETADEX(UNII: JV039JZZ3A)
EDETATE DISODIUM(UNII: 7FLD91C86K)
METHYLPARABEN(UNII: A2I8C7HI9T)
NIACINAMIDE(UNII: 25X51I8RD4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(UNII: ZYD53NBL45)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-630-451 in 1 CARTON 09/06/2021
145 g in 1 TUBE Type 0: Not a Combination Product
2NDC:62332-630-601 in 1 CARTON 09/06/2021
260 g in 1 TUBE Type 0: Not a Combination Product
3NDC:62332-630-551 in 1 CARTON 09/06/2021
355 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 ANDA212646 09/06/2021

LABELER - Alembic Pharmaceuticals, Inc.(079288842)

REGISTRANT - Alembic Pharmaceuticals Limited(650574663)

Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 871411532 MANUFACTURE(62332-630), ANALYSIS(62332-630)

PRINCIPAL DISPLAY PANEL

Metronidazole Gel USP, 1%

For Topical Use Only

NDC 62332-630-45

Rx Only

45 grams

For topical use only.

Not for oral, ophthalmic or intravaginal use.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Usual dosage: Apply a thin film once a day to affected areas.  See prescribing information for complete instructions.

Each gram contains: 10 mg (1%) metronidazole USP, as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben, and purified water.

Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

Manufactured by:

Alembic Pharmaceuticals Limited

(Derma Division),

Karakhadi, Vadodara 391450, India.

Mfg. License No.: G/25/2216

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