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 (XL), for oral use Initial U.S. Approval: 1985
Approved
Approval ID
0abd64f7-5142-48f6-a487-3f5bdc3400de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2023
Manufacturers
FDA
Cipla USA., Inc.
DUNS: 078719707
Products 2
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 Code69097-071
Application NumberANDA207479
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 20, 2023
Generic NameBupropion hydrochloride
INGREDIENTS (13)
BUPROPION HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
Bupropion hydrochloride
PRODUCT DETAILS
NDC Product Code69097-072
Application NumberANDA207479
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 20, 2023
Generic NameBupropion hydrochloride
INGREDIENTS (13)
BUPROPION HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive
Code: XRK36F13ZZ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT