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 use Initial U.S. Approval: 1985
Approved
Approval ID
092da413-ec60-4577-ac57-51e3e42d55c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
ScieGen Pharmaceuticals, Inc.
DUNS: 079391286
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-174
Application NumberANDA205794
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (15)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-175
Application NumberANDA205794
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (16)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50228-176
Application NumberANDA205794
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (15)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB