Letrozole

Product NDC
68071-2167
11-digit product format
680712167
Labeler code
68071
Product ID
68071-2167_1b409bb6-209f-1ce8-e063-6394a90ac12a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090934
Marketing category
ANDA
Marketing start
2011-06-02
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2167-4Letrozole40 in 1 BOTTLETABLET, FILM COATED401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2167LETROZOLE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240627_1b408ba8-05f7-1cf1-e063-6394a90a42bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN1b408ba8-05f7-1cf1-e063-6394a90a42bc1
200064letrozole 2.5 MG Oral TabletSCD1b408ba8-05f7-1cf1-e063-6394a90a42bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-2167-46807121670440 TABLET, FILM COATED in 1 BOTTLE (68071-2167-4) 2024-06-19NoNoCurrent