BUPROPION HYDROCHLORIDE
These highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR).BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR), for oral useInitial U.S. Approval: 1985
Approved
Approval ID
9fb44e96-6160-4a4a-90cb-91764c0dcd89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
Products 3
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 Code42806-410
Application NumberANDA075932
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 29, 2022
Generic NameBUPROPION HYDROCHLORIDE
INGREDIENTS (10)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
BUPROPION HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code42806-415
Application NumberANDA075932
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 29, 2022
Generic NameBUPROPION HYDROCHLORIDE
INGREDIENTS (11)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
BUPROPION HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code42806-411
Application NumberANDA075932
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 29, 2022
Generic NameBUPROPION HYDROCHLORIDE
INGREDIENTS (11)
BUPROPION HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT