Letrozole

Product NDC
42254-243
11-digit product format
422540243
Labeler code
42254
Product ID
42254-243_0193faa4-9b02-4ccd-9751-de6124cc8c68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA090289
Marketing category
ANDA
Marketing start
2011-06-03
Marketing end
0000-00-00
Substance
LETROZOLE
Active strength
3 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-243-30Letrozole30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-243-30EA - Each42254-243f51ee947-ae48-4579-89ec-3e80401d70a712013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LETROZOLEACTIVE INGREDIENT7LKK855W8ILETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LETROZOLEACTIVE MOIETY7LKK855W8ILETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]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 YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]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
42254-243LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130228_0193faa4-9b02-4ccd-9751-de6124cc8c68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN0193faa4-9b02-4ccd-9751-de6124cc8c681
200064letrozole 2.5 MG Oral TabletSCD0193faa4-9b02-4ccd-9751-de6124cc8c681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-243-304225402433030 in 1 BOTTLEHistorical