Bupropion Hydrochloride
These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion Hydrochloride Extended-Release Tablets, USP (XL) for oral useInitial U.S. Approval: 1985
Approved
Approval ID
653cf774-2996-4bc2-b88f-8b4b0eb2e08c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 10, 2015
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
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
NDC Product Code55648-102
Application NumberANDA202189
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 10, 2015
Generic NameBupropion Hydrochloride
INGREDIENTS (17)
BUPROPION HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
AMMONIUM CHLORIDEInactive
Code: 01Q9PC255D
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT