FDA.reportPublic FDA data

Letrozole

Product NDC
63850-0025
11-digit product format
638500025
Labeler code
63850
Product ID
63850-0025_7917d6e0-df93-4c10-97c9-3d90b00b7bd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma Limited
Application
ANDA200161
Marketing category
ANDA
Marketing start
2011-06-03
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
63850-0025-12020-11-18C16284748780-19d75b9d0-a86d-f424-e053-dadaa90a57ceThese 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
63850-0025-22020-11-18C16284748780-19d75b9d0-a86d-f424-e053-dadaa90a57ceThese 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
63850-0025-12020-01-31C16284748780-19d75b9d0-a86d-f424-e053-dadaa90a57ceThese 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
63850-0025-22020-01-31C16284748780-19d75b9d0-a86d-f424-e053-dadaa90a57ceThese 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
63850-0025-1Letrozole30 in 1 BOTTLETABLET308
63850-0025-4Letrozole1000 in 1 BOTTLETABLET10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63850-0025LETROZOLE TABLET [NATCO PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20201119_35c73219-c39e-4e10-b944-76009b061e79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN35c73219-c39e-4e10-b944-76009b061e798
200064letrozole 2.5 MG Oral TabletSCD35c73219-c39e-4e10-b944-76009b061e798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63850-0025-16385000250130 TABLET in 1 BOTTLE (63850-0025-1) 30 tablet2011-06-030000-00-00NoNoCurrent
63850-0025-4638500025041000 TABLET in 1 BOTTLE (63850-0025-4) 1000 tablet2011-06-030000-00-00NoNoCurrent