NDC Code(s) : 0115-1701-49
Packager : Amneal Pharmaceuticals of New York LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Albendazolealbendazole TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1701
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBENDAZOLE(UNII: F4216019LN)
(ALBENDAZOLE - UNII:F4216019LN) 		ALBENDAZOLE200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SACCHARIN SODIUM MONOHYDRATE(UNII: A9CO00M9HV)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (cirular) Size 12 mm
Flavor Imprint Code ap;550
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1701-492 in 1 BOTTLE Type 0: Not a Combination Product06/11/1996
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020666 06/11/1996

LABELER - Amneal Pharmaceuticals of New York LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
GlaxoSmithKline Inc. 205556368 analysis(0115-1701), manufacture(0115-1701), pack(0115-1701)

PRINCIPAL DISPLAY PANEL

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