NDC Code(s) : 63629-5636-1, 63629-5636-2
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Primaquine PhosphatePrimaquine Phosphate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-5636(NDC:0024-1596)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRIMAQUINE PHOSPHATE(UNII: H0982HF78B)
(PRIMAQUINE - UNII:MVR3634GX1) 		PRIMAQUINE15 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax(UNII: R12CBM0EIZ)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
Magnesium Stearate(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Polyethylene Glycol 400(UNII: B697894SGQ)
Polysorbate 80(UNII: 6OZP39ZG8H)
Ferric Oxide Red(UNII: 1K09F3G675)
Talc(UNII: 7SEV7J4R1U)
Titanium Dioxide(UNII: 15FIX9V2JP)
Hypromellose 2910 (15000 MPA.S)(UNII: 288VBX44JC)
Starch, Corn(UNII: O8232NY3SJ)
Product Characteristics
Color PINK Score no score
Shape ROUND (convex, discoid) Size 11 mm
Flavor Imprint Code W;P97
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-5636-1 14 in 1 BOTTLE Type 0: Not a Combination Product17/04/2015
2NDC:63629-5636-2 28 in 1 PACKAGE Type 0: Not a Combination Product17/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA008316 04/15/2011 10/30/2016

PRINCIPAL DISPLAY PANEL

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