FDA.reportPublic FDA data

Letrozole

Product NDC
68071-5264
11-digit product format
680715264
Labeler code
68071
Product ID
68071-5264_2a849ae9-3398-4642-e063-6394a90a1ca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090934
Marketing category
ANDA
Marketing start
2011-06-02
Substance
LETROZOLE
Active strength
2.5 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LETROZOLE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7LKK855W8I
Rxcui200064

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5264-32024-07-03C16284748780-1d6a99b39-598e-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. LETROZOLE tablets, for oral use Initial U.S. Approval: 1997
68071-5264-32022-01-28C16284748780-1d6a99b39-598e-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. LETROZOLE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5264-3Letrozole30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5264LETROZOLE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20250101_a707ec4b-8d26-55c2-e053-2a95a90a2e07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSNa707ec4b-8d26-55c2-e053-2a95a90a2e074
200064letrozole 2.5 MG Oral TabletSCDa707ec4b-8d26-55c2-e053-2a95a90a2e074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5264-36807152640330 TABLET, FILM COATED in 1 BOTTLE (68071-5264-3) 2020-06-010000-00-00NoNoCurrent