FDA.reportPublic FDA data

Fareston

Product NDC
42747-327
11-digit product format
427470327
Labeler code
42747
Product ID
42747-327_11857fbe-6c5e-485e-b5d4-7f091a331928
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
toremifene citrate
Dosage form
TABLET
Route
ORAL
Labeler
Kyowa Kirin, Inc.
Application
NDA020497
Marketing category
NDA
Marketing start
1997-06-30
Substance
TOREMIFENE CITRATE
Active strength
60 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fareston
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOREMIFENE CITRATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2498Y783QT
Rxcui152880, 313428

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9035551b-ebf8-a976-cb3b-cc63e64b2c1dProduct name320210312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42747-327-30Fareston30 in 1 BOTTLETABLET3011
42747-327-72Fareston7 in 1 BLISTER PACKTABLET711

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42747-327-30EA - Each42747-3277443efda-7526-4ae4-8f77-71339bd5c61d12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOREMIFENE CITRATEACTIVE INGREDIENT2498Y783QTFARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
TOREMIFENEACTIVE MOIETY7NFE54O27TFARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EFARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42747-327FARESTON (TOREMIFENE CITRATE) TABLET [KYOWA KIRIN, INC.]11Current NDC, Legacy NDC, 2 package rows20241115_2cab8dd1-3a10-48e6-86ce-0e5275ed49e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152880Fareston GTx 60 MG Oral TabletPSN2cab8dd1-3a10-48e6-86ce-0e5275ed49e511
313428toremifene citrate 60 MG Oral TabletPSN2cab8dd1-3a10-48e6-86ce-0e5275ed49e511
152880toremifene 60 MG Oral Tablet [Fareston]SBD2cab8dd1-3a10-48e6-86ce-0e5275ed49e511
313428toremifene 60 MG Oral TabletSCD2cab8dd1-3a10-48e6-86ce-0e5275ed49e511
152880Fareston 60 MG Oral TabletSY2cab8dd1-3a10-48e6-86ce-0e5275ed49e511
313428toremifene (as toremifene citrate 88.5 MG) Oral TabletSY2cab8dd1-3a10-48e6-86ce-0e5275ed49e511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42747-327-304274703273030 TABLET in 1 BOTTLE (42747-327-30) 30 tablet1997-06-300000-00-00NoNoCurrent
42747-327-72427470327727 TABLET in 1 BLISTER PACK (42747-327-72) 7 tablet1997-06-300000-00-00NoNoCurrent