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
334e5635-e4cc-cf2a-e063-6294a90ae1e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2025
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-899
Application NumberANDA206975
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupropion Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2025
FDA Product Classification
INGREDIENTS (13)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB