FDA.reportPublic FDA data

Letrozole

Product NDC
63629-7819
11-digit product format
636297819
Labeler code
63629
Product ID
63629-7819_c67cb0be-9b22-468d-a969-769b42adfd5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Letrozole
Listing expiration
2027-12-31

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
63629-7819-12020-12-08C16284748780-19d75b9d0-cc4c-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
63629-7819-22020-12-08C16284748780-19d75b9d0-cc4c-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
63629-7819-12020-01-31C16284748780-19d75b9d0-cc4c-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
63629-7819-22020-01-31C16284748780-19d75b9d0-cc4c-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
63629-7819-1Letrozole30 in 1 BOTTLETABLET, FILM COATED309
63629-7819-2Letrozole10 in 1 BOTTLETABLET, FILM COATED109
63629-7819-3Letrozole90 in 1 BOTTLETABLET, FILM COATED909
63629-7819-4Letrozole40 in 1 BOTTLETABLET, FILM COATED409

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7819LETROZOLE TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 4 package rows20240502_26dcb6ee-74d8-4804-b151-79a41484979b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN26dcb6ee-74d8-4804-b151-79a41484979b9
200064letrozole 2.5 MG Oral TabletSCD26dcb6ee-74d8-4804-b151-79a41484979b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7819-16362978190130 TABLET, FILM COATED in 1 BOTTLE (63629-7819-1) 2026-04-030000-00-00NoNoCurrent
63629-7819-26362978190210 TABLET, FILM COATED in 1 BOTTLE (63629-7819-2) 2026-04-030000-00-00NoNoCurrent
63629-7819-36362978190390 TABLET, FILM COATED in 1 BOTTLE (63629-7819-3) 2026-04-030000-00-00NoNoCurrent
63629-7819-46362978190440 TABLET, FILM COATED in 1 BOTTLE (63629-7819-4) 2026-04-030000-00-00NoNoCurrent