Exemestane

Product NDC
71921-190
11-digit product format
719210190
Labeler code
71921
Product ID
71921-190_28c7c528-d203-40c9-a06f-cbe4b0d73326
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Exemestane
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA213547
Marketing category
ANDA
Marketing start
2021-01-15
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
1fe6d34b-d50f-eeb9-bd0c-3f0d6b635985Product name920230126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
71921-190-09Exemestane90 in 1 BOTTLETABLET, FILM COATED905
71921-190-33Exemestane30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-190-33EA - Each71921-190de202ef0-a6a2-43ab-ac98-15a5350db9f712021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-190EXEMESTANE TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]4Current NDC, Legacy NDC, 2 package rows20230621_9354d1a1-8e8c-4c6a-b7ad-d4fe14b10a8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310261exemestane 25 MG Oral TabletPSN9354d1a1-8e8c-4c6a-b7ad-d4fe14b10a8b5
310261exemestane 25 MG Oral TabletSCD9354d1a1-8e8c-4c6a-b7ad-d4fe14b10a8b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71921-190-097192101900990 in 1 BOTTLEHistorical
71921-190-337192101903330 TABLET, FILM COATED in 1 BOTTLE (71921-190-33) 2021-01-150000-00-00NoNoCurrent