FDA.reportPublic FDA data

CABOMETYX

Product NDC
42388-025
11-digit product format
423880025
Labeler code
42388
Product ID
42388-025_e8cdcbdc-d863-4d48-af3e-a8926b9ab017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cabozantinib
Dosage form
TABLET
Route
ORAL
Labeler
Exelixis, Inc.
Application
NDA208692
Marketing category
NDA
Marketing start
2016-04-25
Substance
CABOZANTINIB S-MALATE
Active strength
40 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase 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
CABOMETYX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CABOZANTINIB S-MALATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDR7ST46X58
Rxcui1790161, 1790167, 1790169, 1790171, 1790173, 1790175

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
65d47554-a3d1-410a-ba76-f92410864ab0Product name120160616
ade5b235-a9b4-e445-bdbd-7d75ec61ea16Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42388-025-262025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-262025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-372025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-372025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-462025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-462025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-572025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-572025-02-04C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-262025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-262025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-372025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-372025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-462025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-462025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-572025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012
42388-025-572025-01-30C16284748780-12cef2736-599a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CABOMETYX safely and effectively. See full prescribing information for CABOMETYX. CABOMETYX ® (cabozantinib) tablets, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42388-025-26CABOMETYX30 in 1 BOTTLETABLET3018
42388-025-37CABOMETYX15 in 1 BOTTLETABLET1518
42388-025-46CABOMETYX1 in 1 CARTONTABLET118
42388-025-46CABOMETYX30 in 1 BOTTLETABLET3018
42388-025-57CABOMETYX15 in 1 BOTTLETABLET1518
42388-025-57CABOMETYX1 in 1 CARTONTABLET118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42388-025-26EA - Each42388-025c7c37170-4e5c-4c19-a27a-02fb76298d1412016-05-16
42388-025-46EA - Each42388-025ff6dc49f-86e0-4ae4-b898-0166c9b0a31c12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42388-025CABOMETYX (CABOZANTINIB) TABLET [EXELIXIS, INC.]16Current NDC, Legacy NDC, 6 package rows20250406_3850cce2-6137-42e5-a792-d318c4a4b3b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790167Cabometyx 20 MG Oral TabletPSN3850cce2-6137-42e5-a792-d318c4a4b3b518
1790171Cabometyx 40 MG Oral TabletPSN3850cce2-6137-42e5-a792-d318c4a4b3b518
1790175Cabometyx 60 MG Oral TabletPSN3850cce2-6137-42e5-a792-d318c4a4b3b518
1790161cabozantinib 20 MG Oral TabletPSN3850cce2-6137-42e5-a792-d318c4a4b3b518
1790169cabozantinib 40 MG Oral TabletPSN3850cce2-6137-42e5-a792-d318c4a4b3b518
1790173cabozantinib 60 MG Oral TabletPSN3850cce2-6137-42e5-a792-d318c4a4b3b518
1790167cabozantinib 20 MG Oral Tablet [Cabometyx]SBD3850cce2-6137-42e5-a792-d318c4a4b3b518
1790171cabozantinib 40 MG Oral Tablet [Cabometyx]SBD3850cce2-6137-42e5-a792-d318c4a4b3b518
1790175cabozantinib 60 MG Oral Tablet [Cabometyx]SBD3850cce2-6137-42e5-a792-d318c4a4b3b518
1790161cabozantinib 20 MG Oral TabletSCD3850cce2-6137-42e5-a792-d318c4a4b3b518
1790169cabozantinib 40 MG Oral TabletSCD3850cce2-6137-42e5-a792-d318c4a4b3b518
1790173cabozantinib 60 MG Oral TabletSCD3850cce2-6137-42e5-a792-d318c4a4b3b518
1790167Cabometyx 20 MG (as cabozantinib (S)-malate 25 MG) Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790167Cabometyx 20 MG Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790171Cabometyx 40 MG (as cabozantinib (S)-malate 51 MG) Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790171Cabometyx 40 MG Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790175Cabometyx 60 MG (as cabozantinib (S)-malate 76 MG) Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790175Cabometyx 60 MG Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790161cabozantinib 20 MG (as cabozantinib (S)-malate 25 MG) Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790169cabozantinib 40 MG (as cabozantinib (S)-malate 51 MG) Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518
1790173cabozantinib 60 MG (as cabozantinib (S)-malate 76 MG) Oral TabletSY3850cce2-6137-42e5-a792-d318c4a4b3b518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42388-025-264238800252630 TABLET in 1 BOTTLE (42388-025-26) 30 tablet2016-04-250000-00-00NoNoCurrent
42388-025-374238800253715 TABLET in 1 BOTTLE (42388-025-37) 15 tablet2019-02-270000-00-00YesNoCurrent
42388-025-46423880025461 BOTTLE in 1 CARTON (42388-025-46) / 30 TABLET in 1 BOTTLE1 bottle2023-01-09NoNoHistorical
42388-025-57423880025571 BOTTLE in 1 CARTON (42388-025-57) / 15 TABLET in 1 BOTTLE1 bottle2023-01-09YesNoHistorical