NDC 63629-4383-3
API & Excipient Details

Losartan Potassium marketed by Bryant Ranch Prepack under NDC Code 63629-4383-3

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOSARTAN POTASSIUM(UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)	LOSARTAN POTASSIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-4383-1	30 in 1 BOTTLE Type 0: Not a Combination Product	04/10/2010
2	NDC:63629-4383-3	90 in 1 BOTTLE Type 0: Not a Combination Product	04/10/2010
3	NDC:63629-4383-2	60 in 1 BOTTLE Type 0: Not a Combination Product	04/10/2010
4	NDC:63629-4383-4	120 in 1 BOTTLE Type 0: Not a Combination Product	17/11/2010
5	NDC:63629-4383-5	100 in 1 BOTTLE Type 0: Not a Combination Product	17/11/2010
6	NDC:63629-4383-6	28 in 1 BOTTLE Type 0: Not a Combination Product	17/11/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078243	10/04/2010

PRINCIPAL DISPLAY PANEL