NDC Code(s) : 63629-6473-1, 63629-6473-2, 63629-6473-3
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-6473(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 (1200000 MW)(UNII: RFW2ET671P)
SACCHARIN(UNII: FST467XS7D)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
STEARIC ACID(UNII: 4ELV7Z65AP)
POLYVINYL ALCOHOL, UNSPECIFIED(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:63629-6473-1 180 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
2NDC:63629-6473-2 30 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
3NDC:63629-6473-3 60 in 1 BOTTLE Type 0: Not a Combination Product23/09/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078866 09/23/2015

PRINCIPAL DISPLAY PANEL

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