FDA.reportPublic FDA data

Letrozole

Product NDC
0093-7620
11-digit product format
000937620
Labeler code
0093
Product ID
0093-7620_c91fb703-e253-490e-bb1d-48d054d81c6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090289
Marketing category
ANDA
Marketing start
2011-06-03
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
0093-7620-56Letrozole30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7620-56EA - Each0093-762083cec6b1-8f66-43ad-9b90-b726c2bc90f212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LETROZOLEACTIVE INGREDIENT7LKK855W8ILETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
LETROZOLEACTIVE MOIETY7LKK855W8ILETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]4
LETROZOLEACTIVE INGREDIENT7LKK855W8ILETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
LETROZOLEACTIVE INGREDIENT7LKK855W8ILETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LETROZOLEACTIVE MOIETY7LKK855W8ILETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
LETROZOLEACTIVE MOIETY7LKK855W8ILETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]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
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLETROZOLE (LETROZOLE) TABLET, FILM COATED [AVKARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7620LETROZOLE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 1 package rows20250221_8ebda73d-82a3-4b17-8a81-a1f258003d32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN8ebda73d-82a3-4b17-8a81-a1f258003d3215
200064letrozole 2.5 MG Oral TabletSCD8ebda73d-82a3-4b17-8a81-a1f258003d3215
200064letrozole 2.5 MG Oral TabletPSN1524730f-e37d-478c-1956-b113b3ca42a89
200064letrozole 2.5 MG Oral TabletSCD1524730f-e37d-478c-1956-b113b3ca42a89
200064letrozole 2.5 MG Oral TabletPSN0193faa4-9b02-4ccd-9751-de6124cc8c681
200064letrozole 2.5 MG Oral TabletPSNe1390a0d-0280-49a5-a2d4-d2e13e9952ca1
200064letrozole 2.5 MG Oral TabletSCD0193faa4-9b02-4ccd-9751-de6124cc8c681
200064letrozole 2.5 MG Oral TabletSCDe1390a0d-0280-49a5-a2d4-d2e13e9952ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7620-280009376202828 TABLET, FILM COATED in 1 BOTTLE (0093-7620-28) 2011-06-030000-00-00NoNoCurrent
0093-7620-560009376205630 TABLET, FILM COATED in 1 BOTTLE (0093-7620-56) 2011-06-030000-00-00NoNoCurrent