NDC Code(s) : 63629-4383-1, 63629-4383-3, 63629-4383-2, 63629-4383-4, 63629-4383-5, 63629-4383-6
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Losortan PotassiumLosartan Potassium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-4383(NDC:68382-137)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM(UNII: 3ST302B24A)
(LOSARTAN - UNII:JMS50MPO89) 		LOSARTAN POTASSIUM100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 12 mm
Flavor Imprint Code Z18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-4383-1 30 in 1 BOTTLE Type 0: Not a Combination Product04/10/2010
2NDC:63629-4383-3 90 in 1 BOTTLE Type 0: Not a Combination Product04/10/2010
3NDC:63629-4383-2 60 in 1 BOTTLE Type 0: Not a Combination Product04/10/2010
4NDC:63629-4383-4 120 in 1 BOTTLE Type 0: Not a Combination Product17/11/2010
5NDC:63629-4383-5 100 in 1 BOTTLE Type 0: Not a Combination Product17/11/2010
6NDC:63629-4383-6 28 in 1 BOTTLE Type 0: Not a Combination Product17/11/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078243 10/04/2010

PRINCIPAL DISPLAY PANEL

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