Bupropion Hydrochloride
BuPROPion hydrochloride extended-release tablets, USP (SR)
Approved
Approval ID
c111fe19-3419-461c-83c9-6d809d6ac6bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-897
Application NumberANDA077455
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupropion Hydrochloride
Product Specifications
Route of AdministrationOCCLUSIVE DRESSING TECHNIQUE
Effective DateSeptember 13, 2011
FDA Product Classification
INGREDIENTS (12)
BUPROPION HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT