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bupropion

These highlights do not include all the information needed to use BUPROPIN HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPIN HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS.BUPROPION hydrochloride extended-release tablets USP (SR) for oral useInitial U.S. Approval: 1985

Approved
Approval ID

39b2d509-1281-4464-9cf1-a94bbc18b84b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2023

Manufacturers
FDA

Solco Healthcare US LLC

DUNS: 828343017

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 Code43547-290
Application NumberANDA202304
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification

INGREDIENTS (9)

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Bupropion hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43547-288
Application NumberANDA202304
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification

INGREDIENTS (8)

BUPROPION HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

bupropion hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43547-289
Application NumberANDA202304
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification

INGREDIENTS (9)

BUPROPION HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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