FDA.reportPublic FDA data

Letrozole

Product NDC
71335-2396
11-digit product format
713352396
Labeler code
71335
Product ID
71335-2396_77bb27a8-b20e-44eb-b96c-ff1a364a24d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205869
Marketing category
ANDA
Marketing start
2023-06-01
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
71335-2396-1Letrozole30 in 1 BOTTLETABLET, FILM COATED302
71335-2396-2Letrozole10 in 1 BOTTLETABLET, FILM COATED102
71335-2396-3Letrozole90 in 1 BOTTLETABLET, FILM COATED902
71335-2396-4Letrozole40 in 1 BOTTLETABLET, FILM COATED402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2396LETROZOLE (LETROZOLE TABLETS) TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, 4 package rows20250302_6fd92634-c9c5-457e-808c-a4614e8db7db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN6fd92634-c9c5-457e-808c-a4614e8db7db2
200064letrozole 2.5 MG Oral TabletSCD6fd92634-c9c5-457e-808c-a4614e8db7db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2396-17133523960130 TABLET, FILM COATED in 1 BOTTLE (71335-2396-1) 2024-04-19NoNoCurrent
71335-2396-27133523960210 TABLET, FILM COATED in 1 BOTTLE (71335-2396-2) 2025-01-03NoNoCurrent
71335-2396-37133523960390 TABLET, FILM COATED in 1 BOTTLE (71335-2396-3) 2025-01-31NoNoCurrent
71335-2396-47133523960440 TABLET, FILM COATED in 1 BOTTLE (71335-2396-4) 2025-01-31NoNoCurrent