FDA.reportPublic FDA data

Letrozole

Product NDC
42291-374
11-digit product format
422910374
Labeler code
42291
Product ID
42291-374_43f98eed-733e-4c77-e063-6294a90ae1ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA090289
Marketing category
ANDA
Marketing start
2015-01-05
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
42291-374-30Letrozole30 in 1 BOTTLETABLET, FILM COATED309
42291-374-90Letrozole90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-374-30EA - Each42291-37458a38c9e-ab6c-47ad-a946-91b2214264ad12024-02-14
42291-374-90EA - Each42291-374b8dfe654-f119-4f7f-aefc-8e9f05ac024a12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LETROZOLEACTIVE INGREDIENT7LKK855W8ILETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
LETROZOLEACTIVE MOIETY7LKK855W8ILETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-374LETROZOLE TABLET, FILM COATED [AVKARE]8Current NDC, Legacy NDC, 2 package rows20240105_1524730f-e37d-478c-1956-b113b3ca42a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN1524730f-e37d-478c-1956-b113b3ca42a89
200064letrozole 2.5 MG Oral TabletSCD1524730f-e37d-478c-1956-b113b3ca42a89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-374-304229103743030 TABLET, FILM COATED in 1 BOTTLE (42291-374-30) 2024-01-04NoNoHistorical
42291-374-904229103749090 TABLET, FILM COATED in 1 BOTTLE (42291-374-90) 2015-01-050000-00-00NoNoCurrent