FDA.reportPublic FDA data

Letrozole

Product NDC
59651-180
11-digit product format
596510180
Labeler code
59651
Product ID
59651-180_2cd5dbfd-2432-4cea-bee2-6b710b5d28a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA211717
Marketing category
ANDA
Marketing start
2019-01-11
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
59651-180-30Letrozole30 in 1 BOTTLETABLET, FILM COATED304
59651-180-90Letrozole90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-180-30EA - Each59651-180ff670b01-26bc-4406-a018-ea395a783ef312019-08-06
59651-180-90EA - Each59651-180ac17dac7-90f1-4ac6-9a58-5d7c1665ceff12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-180LETROZOLE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20250312_ff7325d2-3383-4ff9-a187-9350e3538640.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSNff7325d2-3383-4ff9-a187-9350e35386404
200064letrozole 2.5 MG Oral TabletSCDff7325d2-3383-4ff9-a187-9350e35386404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-180-305965101803030 TABLET, FILM COATED in 1 BOTTLE (59651-180-30) 2019-01-110000-00-00NoNoCurrent
59651-180-905965101809090 TABLET, FILM COATED in 1 BOTTLE (59651-180-90) 2019-01-110000-00-00NoNoCurrent