FDA.reportPublic FDA data

Letrozole

Product NDC
17856-0032
11-digit product format
178560032
Labeler code
17856
Product ID
17856-0032_38546ba0-8feb-9cf6-e063-6294a90a074c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA090934
Marketing category
ANDA
Marketing start
2020-01-13
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
17856-0032-12025-04-10C16284748780-1d6a99b39-ece8-a426-e053-dadaa90af4c2Letrozole Tablets These 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
17856-0032-12022-01-28C16284748780-1d6a99b39-ece8-a426-e053-dadaa90af4c2Letrozole Tablets These 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
17856-0032-1Letrozole1 in 1 POUCHTABLET, FILM COATED13
17856-0032-1Letrozole100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0032LETROZOLE TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 2 package rows20250412_c10bf97f-f9cf-468a-8a1f-7637f41022e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSNc10bf97f-f9cf-468a-8a1f-7637f41022e43
200064letrozole 2.5 MG Oral TabletSCDc10bf97f-f9cf-468a-8a1f-7637f41022e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0032-117856003201100 POUCH in 1 BOX, UNIT-DOSE (17856-0032-1) / 1 TABLET, FILM COATED in 1 POUCH100 pouch2020-01-130000-00-00NoNoCurrent