Letrozole

Product NDC
69117-0004
11-digit product format
691170004
Labeler code
69117
Product ID
69117-0004_4721d1b1-3a04-27fb-e063-6394a90a7c1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA205869
Marketing category
ANDA
Marketing start
2019-09-05
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69117-0004-1Letrozole30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0004-1EA - Each69117-00047ce4332e-ffe6-41d9-b7df-66dd07017a4312019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0004LETROZOLE (LETROZOLE TABLETS) TABLET, FILM COATED [YILING PHARMACEUTICAL, INC.]9Current NDC, Legacy NDC, 1 package rows20241226_7b00e08c-9a1c-09e0-e053-2a91aa0a7638.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN7b00e08c-9a1c-09e0-e053-2a91aa0a763810
200064letrozole 2.5 MG Oral TabletSCD7b00e08c-9a1c-09e0-e053-2a91aa0a763810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69117-0004-16911700040130 TABLET, FILM COATED in 1 BOTTLE (69117-0004-1) 2019-09-050000-00-00YesNoCurrent