FDA.reportPublic FDA data

COMETRIQ

Product NDC
42388-013
11-digit product format
423880013
Labeler code
42388
Product ID
42388-013_03fee098-20c7-4a04-81a7-06fb7d8b1470
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cabozantinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelixis, Inc.
Application
NDA203756
Marketing category
NDA
Marketing start
2012-11-29
Substance
CABOZANTINIB S-MALATE
Active strength
20 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
COMETRIQ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CABOZANTINIB S-MALATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDR7ST46X58
Rxcui1363273, 1363279, 1363281, 1363284, 1363312, 1363408, 1363409, 1363410, 1364580, 1364581

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
65d47554-a3d1-410a-ba76-f92410864ab0Product name120160616
ade5b235-a9b4-e445-bdbd-7d75ec61ea16Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42388-013-142025-02-04C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012
42388-013-142025-02-04C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012
42388-013-142025-01-30C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012
42388-013-142025-01-30C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012
42388-013-142022-02-10C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012
42388-013-142022-02-10C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012
42388-013-142022-01-28C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012
42388-013-142022-01-28C16284748780-1d6a99b39-63fa-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ. COMETRIQ ® (cabozantinib) capsules, for oral use Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42388-013-14COMETRIQ4 in 1 CARTONCAPSULE416
42388-013-14COMETRIQ21 in 1 BLISTER PACKCAPSULE2116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42388-013-14EA - Each42388-01306d09237-0016-49cd-932c-2988d060de1b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cabozantinib s-malateACTIVE INGREDIENTDR7ST46X58COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
cabozantinibACTIVE MOIETY1C39JW444GCOMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
ammoniaINACTIVE INGREDIENT5138Q19F1XCOMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCOMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LCOMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
shellacINACTIVE INGREDIENT46N107B71OCOMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APCOMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCOMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42388-013COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]15Current NDC, Legacy NDC, 2 package rows20250206_1a0c3bea-c87b-4d25-bb44-5f0174da6b34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363410{28 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 28 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 100 MG Daily Dose Carton]BPCK1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364581{84 (cabozantinib 20 MG Oral Capsule [Cometriq]) } Pack [Cometriq 60 MG Daily Dose Carton]BPCK1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363408{84 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 28 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 140 MG Daily Dose Carton]BPCK1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363409{28 (cabozantinib 20 MG Oral Capsule) / 28 (cabozantinib 80 MG Oral Capsule) } PackGPCK1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364580{84 (cabozantinib 20 MG Oral Capsule) } PackGPCK1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363312{84 (cabozantinib 20 MG Oral Capsule) / 28 (cabozantinib 80 MG Oral Capsule) } PackGPCK1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363409cabozantinib 100 MG Daily Dose, 20 MG (28), 80 MG (28) Oral Capsule PackPSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363312cabozantinib 140 MG Daily Dose, 20 MG (84), 80 MG (28) Oral Capsule PackPSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363273cabozantinib 20 MG Oral CapsulePSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364580cabozantinib 60 MG Daily Dose, 20 MG Oral Capsule 84 Count PackPSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363281cabozantinib 80 MG Oral CapsulePSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363410Cometriq 100 MG Daily Dose Carton PackPSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363408Cometriq 140 MG Daily Dose Carton PackPSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363279Cometriq 20 MG Oral CapsulePSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364581Cometriq 60 MG Daily Dose CartonPSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363284Cometriq 80 MG Oral CapsulePSN1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363279cabozantinib 20 MG Oral Capsule [Cometriq]SBD1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363284cabozantinib 80 MG Oral Capsule [Cometriq]SBD1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363273cabozantinib 20 MG Oral CapsuleSCD1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363281cabozantinib 80 MG Oral CapsuleSCD1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
13645814 {21 (cabozantinib 20 MG Oral Capsule [Cometriq]) } Pack [Cometriq 60 MG Daily Dose Carton]SY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
13634084 {21 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 7 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 140 MG Daily Dose Carton]SY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
13634104 {7 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 7 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 100 MG Daily Dose Carton]SY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363409cabozantinib 100 MG Daily Dose CartonSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363409cabozantinib 100 MG Daily Dose Carton Pack, 4 Blister Cards, 14 Capsules EachSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363312cabozantinib 140 MG Daily Dose CartonSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363312cabozantinib 140 MG Daily Dose Carton Pack, 4 Blister Cards, 28 Capsules EachSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363273cabozantinib 20 MG (as cabozantinib s-malate 25 MG) Oral CapsuleSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364580cabozantinib 60 MG Daily Dose CartonSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364580cabozantinib 60 MG Daily Dose Carton Pack, 4 Blister Cards, 21 Capsules EachSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363281cabozantinib 80 MG (as cabozantinib s-malate 102 MG) Oral CapsuleSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363410Cometriq 100 MG Daily Dose Carton PackSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363410Cometriq 100 MG Daily Dose Carton Pack, 4 Blister Cards, 14 Capsules EachSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363408Cometriq 140 MG Daily Dose Carton PackSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363408Cometriq 140 MG Daily Dose Carton Pack, 4 Blister Cards, 28 Capsules EachSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363279Cometriq 20 MG Oral CapsuleSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364581Cometriq 60 MG Daily Dose Carton PackSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1364581Cometriq 60 MG Daily Dose Carton Pack, 4 Blister Cards, 21 Capsules EachSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416
1363284Cometriq 80 MG Oral CapsuleSY1a0c3bea-c87b-4d25-bb44-5f0174da6b3416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42388-013-14423880013144 BLISTER PACK in 1 CARTON (42388-013-14) / 21 CAPSULE in 1 BLISTER PACK4 blister pack2012-11-290000-00-00NoNoCurrent