EXEMESTANE

Product NDC
69097-316
11-digit product format
690970316
Labeler code
69097
Product ID
69097-316_60b57295-ef43-4721-94c4-58a4c5689420
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
exemestane
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA210323
Marketing category
ANDA
Marketing start
2018-04-27
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
69097-316-02EXEMESTANE30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-316-02EA - Each69097-316ae83ca44-5122-4fa9-bbec-cee16c27e47712018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-316EXEMESTANE TABLET [CIPLA USA INC.]7Current NDC, Legacy NDC, 1 package rows20250121_abde1ccd-0ec9-40d4-b205-fbc00f5878b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310261exemestane 25 MG Oral TabletPSNabde1ccd-0ec9-40d4-b205-fbc00f5878b97
310261exemestane 25 MG Oral TabletSCDabde1ccd-0ec9-40d4-b205-fbc00f5878b97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-316-026909703160230 TABLET in 1 BOTTLE (69097-316-02) 30 tablet2018-04-270000-00-00NoNoCurrent