FDA.reportPublic FDA data

EXEMESTANE

Product NDC
59762-2858
11-digit product format
597622858
Labeler code
59762
Product ID
59762-2858_6aeb23c4-3f3f-4966-829c-12e7e6ec91ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Exemestane
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020753
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-04-01
Substance
EXEMESTANE
Active strength
25 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
EXEMESTANE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EXEMESTANE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNY22HMQ4BX
Rxcui310261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1fe6d34b-d50f-eeb9-bd0c-3f0d6b635985Product name920230126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-2858-1EXEMESTANE30 in 1 BOTTLETABLET, SUGAR COATED3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-2858-1EA - Each59762-28588b37d6d6-b8a9-4999-8203-4b587eea08ff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EXEMESTANEACTIVE INGREDIENTNY22HMQ4BXEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
EXEMESTANEACTIVE MOIETYNY22HMQ4BXEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
MANNITOLINACTIVE INGREDIENT3OWL53L36AEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
SUCROSEINACTIVE INGREDIENTC151H8M554EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-2858EXEMESTANE TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 1 package rows20250522_69abd0ff-b200-4d1a-b14a-80e980a8e781.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310261exemestane 25 MG Oral TabletPSN69abd0ff-b200-4d1a-b14a-80e980a8e78120
310261exemestane 25 MG Oral TabletSCD69abd0ff-b200-4d1a-b14a-80e980a8e78120

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-2858-15976228580130 TABLET, SUGAR COATED in 1 BOTTLE (59762-2858-1) 2011-04-010000-00-00NoNoCurrent