LETROZOLE

Product NDC
50268-476
11-digit product format
502680476
Labeler code
50268
Product ID
50268-476_48d4cf4a-83a7-4e5f-e063-6394a90a4ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LETROZOLE
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA200161
Marketing category
ANDA
Marketing start
2019-10-02
Substance
LETROZOLE
Active strength
2.5 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LETROZOLE
Listing expiration
2027-12-31

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
50268-476-11LETROZOLE1 in 1 BLISTER PACKTABLET15
50268-476-15LETROZOLE50 in 1 BOXTABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-476-11EA - Each50268-476ea96e760-0007-4407-adc2-d155e9dda7e812019-11-12
50268-476-15EA - Each50268-4763722763c-54ff-4338-9b55-6d9098fe2b0112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-476LETROZOLE TABLET [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_93f317f1-96d1-498e-e053-2995a90ac60d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN93f317f1-96d1-498e-e053-2995a90ac60d5
200064letrozole 2.5 MG Oral TabletSCD93f317f1-96d1-498e-e053-2995a90ac60d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-476-11502680476111 in 1 BLISTER PACKHistorical
50268-476-155026804761550 BLISTER PACK in 1 BOX (50268-476-15) / 1 TABLET in 1 BLISTER PACK (50268-476-11) 50 blister pack2019-10-020000-00-00NoNoCurrent