Bupropion hydrochloride tablet

Inactive ingredient

COLLOIDAL SILICON DIOXIDE


FD&C BLUE NO. 2


FD&C YELLOW NO. 6


GLUTAMIC ACID HYDROCHLORIDE


HYDROXYPROPYL CELLULOSE


HYPROMELLOSE


MAGNESIUM STEARATE


MALEIC ACID


CELLULOSE, MICROCRYSTALLINE


POLYETHYLENE GLYCOL 400


POLYETHYLENE GLYCOL 6000


TALC


TITANIUM DIOXIDE


D&C YELLOW NO. 10



Ingredients and appearance - Product information

Bupropion hydrochloride tablet- Bupropion hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-652
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Bupropion hydrochloride ( UNII: ZG7E5POY8O)( Bupropion - UNII: 01ZG3TPX31 ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Glutamic acid hydrochloride ( UNII: M0C2SP444T)
Hydroxypropyl cellulose ( UNII: RFW2ET671P)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Maleic acid ( UNII: 91XW058U2C)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)

Product Characteristics

Color yellow Score 1
Shape ROUND (TABLET) Imprint Code 93;280
Size 10 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-652-02 30 in 1 BLISTER PACK 2011/03/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075310 USA 2011/03/11

Labeler - REMEDYREPACK INC.( 829572556)