FDA.reportPublic FDA data

Exemestane

Product NDC
51991-005
11-digit product format
519910005
Labeler code
51991
Product ID
51991-005_cb46b87b-4bbc-4aed-8656-877a480061af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Exemestane
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA211031
Marketing category
ANDA
Marketing start
2019-12-19
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-005-33Exemestane30 in 1 BOTTLETABLET, FILM COATED3010
51991-005-90Exemestane90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-005-33EA - Each51991-005f306df0f-d83e-4df7-8dd4-e6110bd23e7112020-01-03
51991-005-90EA - Each51991-0055ec11b66-dab9-47fa-a9c1-8713506f742012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-005EXEMESTANE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]10Current NDC, Legacy NDC, 2 package rows20250115_4e3fd382-19f5-4ded-ab22-39d5b1b2f366.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310261exemestane 25 MG Oral TabletPSN1841ec12-3f4f-4b87-b719-fd0b4d9eaffb104
310261exemestane 25 MG Oral TabletSCD1841ec12-3f4f-4b87-b719-fd0b4d9eaffb104
310261exemestane 25 MG Oral TabletPSN4e3fd382-19f5-4ded-ab22-39d5b1b2f36610
310261exemestane 25 MG Oral TabletSCD4e3fd382-19f5-4ded-ab22-39d5b1b2f36610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-005-335199100053330 TABLET, FILM COATED in 1 BOTTLE (51991-005-33) 2019-12-190000-00-00NoNoCurrent
51991-005-905199100059090 TABLET, FILM COATED in 1 BOTTLE (51991-005-90) 2020-11-150000-00-00NoNoCurrent