NDC Code(s) : 60760-817-90
Packager : St Marys Medical Park Pharmacy

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupropion Hydrochloridebupropion hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-817(NDC:0378-0435)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O)
(BUPROPION - UNII:01ZG3TPX31) 		BUPROPION HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
HYDROCHLORIC ACID(UNII: QTT17582CB)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color blue (light blue) Score no score
Shape ROUND Size 12 mm
Flavor Imprint Code M;435
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60760-817-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product22/05/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075491 05/22/2014 08/31/2015

PRINCIPAL DISPLAY PANEL

Bupropion