FDA.reportPublic FDA data

LETROZOLE

Product NDC
51991-759
11-digit product format
519910759
Labeler code
51991
Product ID
51991-759_35b275df-f687-4e29-828b-637d5377cc73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LETROZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA200161
Marketing category
ANDA
Marketing start
2011-06-04
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
51991-759-10LETROZOLE1000 in 1 BOTTLETABLET100011
51991-759-33LETROZOLE30 in 1 BOTTLETABLET3011
51991-759-90LETROZOLE90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-759-10EA - Each51991-75992be9c9c-0f1a-4436-81e8-e952e697e07112012-07-24
51991-759-33EA - Each51991-759589924c7-2265-4455-9e0b-dc1a5deb127a12012-07-24
51991-759-90EA - Each51991-759facf04f1-9588-4989-8e4e-be896505323912023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LETROZOLEACTIVE INGREDIENT7LKK855W8ILETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
LETROZOLEACTIVE MOIETY7LKK855W8ILETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-759LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]11Current NDC, Legacy NDC, 3 package rows20240327_63e54b62-a30d-4a56-9215-75e7a0b0bf02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN63e54b62-a30d-4a56-9215-75e7a0b0bf0211
200064letrozole 2.5 MG Oral TabletSCD63e54b62-a30d-4a56-9215-75e7a0b0bf0211
200064letrozole 2.5 MG Oral TabletPSN3cc750a5-cc88-4b42-b4ab-a87e760f291d8
200064letrozole 2.5 MG Oral TabletSCD3cc750a5-cc88-4b42-b4ab-a87e760f291d8
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
51991-759-10519910759101000 TABLET in 1 BOTTLE (51991-759-10) 1000 tablet2011-06-040000-00-00NoNoCurrent
51991-759-335199107593330 TABLET in 1 BOTTLE (51991-759-33) 30 tablet2011-06-040000-00-00NoNoCurrent
51991-759-905199107599090 TABLET in 1 BOTTLE (51991-759-90) 90 tablet2022-10-010000-00-00NoNoCurrent