Bupropion Hydrochloride
These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE tablets safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE tablets. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
Approved
Approval ID
0961f83e-25e9-4ffc-8669-44e4e9169978
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2023
Manufacturers
FDA
Modavar Pharmaceuticals LLC
DUNS: 858949204
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bupropion Hydrochloride
PRODUCT DETAILS
NDC Product Code72241-021
Application NumberANDA208606
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 18, 2023
Generic NameBupropion Hydrochloride
INGREDIENTS (11)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Bupropion Hydrochloride
PRODUCT DETAILS
NDC Product Code72241-020
Application NumberANDA208606
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 18, 2023
Generic NameBupropion Hydrochloride
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT