Bupropion Hydrochloride

Basic Information

Product Name

FDA Product Code

70518-1566

Regulatory Information

NDC Product Code

70518-1566

Application Number

ANDA076143

Marketing Category

C73584

Effective Date

February 21, 2024

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FUMARIC ACID

Code: 88XHZ13131

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

METHYLCELLULOSE (100 MPA.S)

Code: 4GFU244C4J

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

BUPROPION HYDROCHLORIDE

Quantity: 75 mg in 1 1

Code: ZG7E5POY8O

Class Code: ACTIB

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

Active Moieties

BUPROPION

Code: 01ZG3TPX31

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSPOVIDONE (120 .MU.M)

SILICON DIOXIDE

FUMARIC ACID

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

POLYETHYLENE GLYCOL 8000

MAGNESIUM STEARATE

METHYLCELLULOSE (100 MPA.S)

HYPROMELLOSE, UNSPECIFIED

TITANIUM DIOXIDE

FD&C YELLOW NO. 6

Active Moieties

BUPROPION