FDA.reportPublic FDA data

LETROZOLE

Product NDC
62135-491
11-digit product format
621350491
Labeler code
62135
Product ID
62135-491_456ed484-059b-2ee9-e063-6294a90a3f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA205869
Marketing category
ANDA
Marketing start
2019-05-09
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
62135-491-30LETROZOLE30 in 1 BOTTLETABLET, FILM COATED305
62135-491-90LETROZOLE90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-491-30EA - Each62135-4917387c2b3-c0c3-464f-80c0-b123d3e7b3f612022-02-07
62135-491-90EA - Each62135-491afff68d6-aff6-4041-92e3-b43155bcb7bd12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-491LETROZOLE TABLET, FILM COATED [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 2 package rows20241030_fa2d40a5-3504-44ef-8f5c-aa4c06308074.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSNfa2d40a5-3504-44ef-8f5c-aa4c063080745
200064letrozole 2.5 MG Oral TabletSCDfa2d40a5-3504-44ef-8f5c-aa4c063080745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-491-306213504913030 TABLET, FILM COATED in 1 BOTTLE (62135-491-30) 2022-01-170000-00-00NoNoCurrent
62135-491-906213504919090 TABLET, FILM COATED in 1 BOTTLE (62135-491-90) 2022-01-170000-00-00NoNoCurrent