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 use Initial U.S. Approval: 1985
Approved
Approval ID
57010a66-792b-408b-929b-5a7d1ae76756
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
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 Code70518-2641
Application NumberANDA202304
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2025
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT