FDA.reportPublic FDA data

Letrozole

Product NDC
71205-587
11-digit product format
712050587
Labeler code
71205
Product ID
71205-587_e1390a0d-0280-49a5-a2d4-d2e13e9952ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090289
Marketing category
ANDA
Marketing start
2011-06-03
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-587-30Letrozole30 in 1 BOTTLETABLET, FILM COATED301
71205-587-60Letrozole60 in 1 BOTTLETABLET, FILM COATED601
71205-587-90Letrozole90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-587LETROZOLE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20210713_e1390a0d-0280-49a5-a2d4-d2e13e9952ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSNe1390a0d-0280-49a5-a2d4-d2e13e9952ca1
200064letrozole 2.5 MG Oral TabletSCDe1390a0d-0280-49a5-a2d4-d2e13e9952ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-587-307120505873030 TABLET, FILM COATED in 1 BOTTLE (71205-587-30) 2021-07-070000-00-00NoNoCurrent
71205-587-607120505876060 TABLET, FILM COATED in 1 BOTTLE (71205-587-60) 2021-07-070000-00-00NoNoCurrent
71205-587-907120505879090 TABLET, FILM COATED in 1 BOTTLE (71205-587-90) 2021-07-070000-00-00NoNoCurrent