NDC Code(s) : 43063-976-30, 43063-976-90
Packager : PD-Rx 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:43063-976(NDC:53489-157)
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
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
POVIDONE(UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C YELLOW NO. 6 ALUMINUM LAKE(UNII: GYP6Z2JR6Q)
Product Characteristics
Color orange Score 2 pieces
Shape ROUND Size 12 mm
Flavor Imprint Code MP;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-976-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/08/2019
2NDC:43063-976-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/04/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071450 01/09/1987

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-976)

PRINCIPAL DISPLAY PANEL

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