NDC Code(s) : 45865-662-30
Packager : Medsource Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion hydrochlorideBupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-662(NDC:47335-737)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
SACCHARIN(UNII: FST467XS7D)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
STEARIC ACID(UNII: 4ELV7Z65AP)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 737
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45865-662-3030 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078866 04/08/2010

PRINCIPAL DISPLAY PANEL

pdp