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FDA Product

Bupropion Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Bupropion Hydrochloride

50436-1580

Regulatory Information

50436-1580

ANDA076143

C73584

November 23, 2018

USA

These highlights do not include all the information needed to use HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Unit Dose Services

831995316

Active Ingredients

BUPROPION HYDROCHLORIDE

Quantity: 75 mg in 1 1

Code: ZG7E5POY8O

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

FUMARIC ACID

Code: 88XHZ13131

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

METHYLCELLULOSE (100 MPA.S)

Code: 4GFU244C4J

Class Code: IACT

Polyethylene Glycol 8000

Code: Q662QK8M3B

Class Code: IACT

Active Moieties

BUPROPION

Code: 01ZG3TPX31

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