Exemestane

Product NDC
59651-516
11-digit product format
596510516
Labeler code
59651
Product ID
59651-516_498de360-2fc1-4fcf-aa53-54eab01cba43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Exemestane
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216454
Marketing category
ANDA
Marketing start
2022-05-20
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
59651-516-30Exemestane30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-516-30EA - Each59651-516f7af11b6-d6aa-4867-bb75-83c183665a5e12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-516EXEMESTANE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 1 package rows20250501_e24b08eb-4693-41c7-81cb-b536947f7070.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310261exemestane 25 MG Oral TabletPSNe24b08eb-4693-41c7-81cb-b536947f70702
310261exemestane 25 MG Oral TabletSCDe24b08eb-4693-41c7-81cb-b536947f70702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-516-305965105163030 TABLET, FILM COATED in 1 BOTTLE (59651-516-30) 2022-05-200000-00-00NoNoCurrent