Forfivo
These highlights do not include all the information needed to use FORFIVO XL safely and effectively. See full prescribing information for FORFIVO XL. FORFIVO XL (bupropion hydrochloride) extended-release tablets, for oral useInitial U.S. Approval: 1985
Approved
Approval ID
80b01182-dc94-4990-8ebb-55c306d7e536
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
NDC Product Code24979-247
Application NumberNDA022497
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 1, 2023
Generic Namebupropion hydrochloride
INGREDIENTS (16)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BUPROPION HYDROCHLORIDEActive
Quantity: 450 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
POLYETHYLENE OXIDE 2000000Inactive
Code: 5K3991GVWI
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT