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 useInitial U.S. Approval: 1985
Approved
Approval ID
98d5977f-9b32-46db-bd36-a2c4d1b0710a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
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 Code24979-248
Application NumberNDA022497
Product Classification
M
Marketing Category
C73605
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2023
FDA Product Classification
INGREDIENTS (16)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYETHYLENE OXIDE 2000000Inactive
Code: 5K3991GVWI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 450 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT