Fareston
These highlights do not include all the information needed to use FARESTON® safely and effectively. See full prescribing information for FARESTON®. FARESTON® (toremifene citrate) 60 mg Tablets oral administration Initial U.S. Approval: 1997
Approved
Approval ID
2cab8dd1-3a10-48e6-86ce-0e5275ed49e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Kyowa Kirin, Inc.
DUNS: 014778321
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
toremifene citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42747-327
Application NumberNDA020497
Product Classification
M
Marketing Category
C73594
G
Generic Name
toremifene citrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TOREMIFENE CITRATEActive
Quantity: 60 mg in 1 1
Code: 2498Y783QT
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT