BUPROPION HYDROCHLORIDE
Approved
Approval ID
0d1715b2-4193-43d6-9a23-0469d6338ea4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 18, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-037
Application NumberANDA075491
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPROPION HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 18, 2011
FDA Product Classification
INGREDIENTS (14)
BUPROPION HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT