toremifene citrate

Product NDC
72205-050
11-digit product format
722050050
Labeler code
72205
Product ID
72205-050_199a7f12-59c6-430f-bc07-a63af2fc7589
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
toremifene citrate
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA212818
Marketing category
ANDA
Marketing start
2020-09-02
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
72205-050-30toremifene citrate30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-050-30EA - Each72205-050ecb97593-f7a5-43fa-b661-86843107dcbd12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-050TOREMIFENE CITRATE TABLET [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 1 package rows20200902_e897546b-4136-4cb5-a262-d94cf3fa3298.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313428toremifene citrate 60 MG Oral TabletPSNe897546b-4136-4cb5-a262-d94cf3fa32982
313428toremifene 60 MG Oral TabletSCDe897546b-4136-4cb5-a262-d94cf3fa32982
313428toremifene (as toremifene citrate 88.5 MG) Oral TabletSYe897546b-4136-4cb5-a262-d94cf3fa32982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-050-307220500503030 TABLET in 1 BOTTLE (72205-050-30) 30 tablet2020-09-020000-00-00NoNoCurrent