NDC Code(s) : 68788-7383-3, 68788-7383-6, 68788-7383-9
Packager : Preferred Pharmaceuticals Inc.

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:68788-7383(NDC:16729-134)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLOPURINOL(UNII: 63CZ7GJN5I)
(ALLOPURINOL - UNII:63CZ7GJN5I) 		ALLOPURINOL100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE K30(UNII: U725QWY32X)
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code AW
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-7383-330 in 1 BOTTLE Type 0: Not a Combination Product13/09/2016
2NDC:68788-7383-660 in 1 BOTTLE Type 0: Not a Combination Product13/09/2016
3NDC:68788-7383-990 in 1 BOTTLE Type 0: Not a Combination Product13/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203154 09/13/2016

LABELER - Preferred Pharmaceuticals Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-7383)

PRINCIPAL DISPLAY PANEL

Allopurinol Tablets 100mg