NDC Code(s) : 0904-6572-61
Packager : Major Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allopurinolallopurinol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6572(NDC:0603-2116)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLOPURINOL(UNII: 63CZ7GJN5I)
(ALLOPURINOL - UNII:63CZ7GJN5I) 		ALLOPURINOL300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 ALUMINUM LAKE(UNII: GYP6Z2JR6Q)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code 2084;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-6572-61100 in 1 CARTON 27/06/2003
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075798 06/27/2003

LABELER - Major Pharmaceuticals(191427277)

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-6572-61

Unit Dose

Allopurinol

Tablets, USP

300 mg

100 TABLETS (10 x 10)

Rx only

300mg carton label