toremifene citrate

Product NDC
64980-404
11-digit product format
649800404
Labeler code
64980
Product ID
64980-404_6aa927e6-a0b9-4904-aa11-e5a3f52cee47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
toremifene citrate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA208813
Marketing category
ANDA
Marketing start
2019-01-18
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
toremifene citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOREMIFENE CITRATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2498Y783QT
Rxcui313428

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
64980-404-03toremifene citrate30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-404-03EA - Each64980-40456246bd2-1fa1-43c6-bff9-efbcbd45f1e912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-404TOREMIFENE CITRATE TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 1 package rows20250509_dbde10d5-c689-428f-841d-b34aa5addf2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313428toremifene citrate 60 MG Oral TabletPSNdbde10d5-c689-428f-841d-b34aa5addf2d4
313428toremifene 60 MG Oral TabletSCDdbde10d5-c689-428f-841d-b34aa5addf2d4
313428toremifene (as toremifene citrate 88.5 MG) Oral TabletSYdbde10d5-c689-428f-841d-b34aa5addf2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-404-036498004040330 TABLET in 1 BOTTLE, PLASTIC (64980-404-03) 30 tablet2019-01-180000-00-00NoNoCurrent