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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42388-013-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42388-013-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42388-013-14	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203756-001	COMETRIQ	CABOZANTINIB S-MALATE	EQ 20MG BASE	CAPSULE / ORAL		RLD	2012-11-29
N203756-002	COMETRIQ	CABOZANTINIB S-MALATE	EQ 80MG BASE	CAPSULE / ORAL		RLD, RS	2012-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26
N203756-001	11091439	2030-01-15		Drug substance	2021-08-31
N203756-001	11091440	2030-01-15		Drug product	2021-08-31
N203756-001	11098015	2030-01-15	U-1617		2021-08-31
N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04
N203756-001	11298349	2032-02-10		Drug product	2022-04-12
N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25
N203756-001	9717720	2032-02-10		Drug product	2017-08-23
N203756-002	7579473	2026-08-14		Drug substance, Drug product
N203756-002	11091439	2030-01-15		Drug substance	2021-08-31
N203756-002	11091440	2030-01-15		Drug product	2021-08-31
N203756-002	11098015	2030-01-15	U-1617		2021-08-31
N203756-002	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04
N203756-002	11298349	2032-02-10		Drug product	2022-04-12
N203756-002	12128039	2032-02-10	U-1617	Drug product	2024-11-25
N203756-002	9717720	2032-02-10		Drug product	2017-08-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203756-001	COMETRIQ	EQ 20MG BASE	CAPSULE / ORAL	RLD, RS	2012-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203756-002	COMETRIQ	EQ 80MG BASE	CAPSULE / ORAL	RLD	2012-11-29	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 550 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11091439	2030-01-15		Drug substance	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11091440	2030-01-15		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11098015	2030-01-15	U-1617		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	11298349	2032-02-10		Drug product	2022-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-001	9717720	2032-02-10		Drug product	2017-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	7579473	2026-08-14		Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11091439	2030-01-15		Drug substance	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11091440	2030-01-15		Drug product	2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11098015	2030-01-15	U-1617		2021-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	11298349	2032-02-10		Drug product	2022-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203756-002	9717720	2032-02-10		Drug product	2017-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11091439	2030-01-15		Drug substance	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11091440	2030-01-15		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11098015	2030-01-15	U-1617		2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	11298349	2032-02-10		Drug product	2022-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-001	9717720	2032-02-10		Drug product	2017-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	7579473	2026-08-14		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11091439	2030-01-15		Drug substance	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11091440	2030-01-15		Drug product	2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11098015	2030-01-15	U-1617		2021-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	11298349	2032-02-10		Drug product	2022-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203756-002	9717720	2032-02-10		Drug product	2017-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203756-001	7579473	2026-08-14		Drug substance, Drug product	2012-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11091439	2030-01-15		Drug substance	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11091440	2030-01-15		Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11098015	2030-01-15	U-1617		2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	8877776	2030-10-08	U-1617	Drug substance, Drug product	2014-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	11298349	2032-02-10		Drug product	2022-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	12128039	2032-02-10	U-1617	Drug product	2024-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203756-001	9717720	2032-02-10		Drug product	2017-08-23	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203756-001	ODE-33	2019-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203756-002	ODE-33	2019-11-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N203756-001	ODE-33	2019-11-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203756-002	ODE-33	2019-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203756-001	ODE-33	2019-11-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203756-002	ODE-33	2019-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203756-001	ODE-33	2019-11-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203756-002	ODE-33	2019-11-29	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: COMETRIQ
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CABOZANTINIB S-MALATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
DR7ST46X58	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1363273	Internal RxNorm lookup
1363279	Internal RxNorm lookup
1363281	Internal RxNorm lookup
1363284	Internal RxNorm lookup
1363312	Internal RxNorm lookup
1363408	Internal RxNorm lookup
1363409	Internal RxNorm lookup
1363410	Internal RxNorm lookup
1364580	Internal RxNorm lookup
1364581	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1a0c3bea-c87b-4d25-bb44-5f0174da6b34	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
65d47554-a3d1-410a-ba76-f92410864ab0	Product name	1	20160616
ade5b235-a9b4-e445-bdbd-7d75ec61ea16	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-02-04	These 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
2025-02-04	These 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
2025-01-30	These 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
2025-01-30	These 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
2022-02-10	These 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
2022-02-10	These 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
2022-01-28	These 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
2022-01-28	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
42388-013-14	COMETRIQ	4 in 1 CARTON	CAPSULE	4		16
42388-013-14	COMETRIQ	21 in 1 BLISTER PACK	CAPSULE	21		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42388-013-14	EA - Each	42388-013	06d09237-0016-49cd-932c-2988d060de1b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cabozantinib s-malate	ACTIVE INGREDIENT	DR7ST46X58	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
cabozantinib	ACTIVE MOIETY	1C39JW444G	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
ammonia	INACTIVE INGREDIENT	5138Q19F1X	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
shellac	INACTIVE INGREDIENT	46N107B71O	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42388-013	COMETRIQ (CABOZANTINIB) KIT COMETRIQ (CABOZANTINIB) CAPSULE [EXELIXIS, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20250206_1a0c3bea-c87b-4d25-bb44-5f0174da6b34.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COMETRIQ	CABOZANTINIB	Exelixis, Inc.	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	2025-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203756 application number: NDA203756 ndc (product): 42388-013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DR7ST46X58	CABOZANTINIB S-MALATE	1140909-48-3	CABOZANTINIB S-MALATE
1C39JW444G	CABOZANTINIB	849217-68-1	cabozantinib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1363410	{28 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 28 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 100 MG Daily Dose Carton]	BPCK	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364581	{84 (cabozantinib 20 MG Oral Capsule [Cometriq]) } Pack [Cometriq 60 MG Daily Dose Carton]	BPCK	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363408	{84 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 28 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 140 MG Daily Dose Carton]	BPCK	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363409	{28 (cabozantinib 20 MG Oral Capsule) / 28 (cabozantinib 80 MG Oral Capsule) } Pack	GPCK	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364580	{84 (cabozantinib 20 MG Oral Capsule) } Pack	GPCK	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363312	{84 (cabozantinib 20 MG Oral Capsule) / 28 (cabozantinib 80 MG Oral Capsule) } Pack	GPCK	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363409	cabozantinib 100 MG Daily Dose, 20 MG (28), 80 MG (28) Oral Capsule Pack	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363312	cabozantinib 140 MG Daily Dose, 20 MG (84), 80 MG (28) Oral Capsule Pack	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363273	cabozantinib 20 MG Oral Capsule	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364580	cabozantinib 60 MG Daily Dose, 20 MG Oral Capsule 84 Count Pack	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363281	cabozantinib 80 MG Oral Capsule	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363410	Cometriq 100 MG Daily Dose Carton Pack	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363408	Cometriq 140 MG Daily Dose Carton Pack	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363279	Cometriq 20 MG Oral Capsule	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364581	Cometriq 60 MG Daily Dose Carton	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363284	Cometriq 80 MG Oral Capsule	PSN	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363279	cabozantinib 20 MG Oral Capsule [Cometriq]	SBD	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363284	cabozantinib 80 MG Oral Capsule [Cometriq]	SBD	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363273	cabozantinib 20 MG Oral Capsule	SCD	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363281	cabozantinib 80 MG Oral Capsule	SCD	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364581	4 {21 (cabozantinib 20 MG Oral Capsule [Cometriq]) } Pack [Cometriq 60 MG Daily Dose Carton]	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363408	4 {21 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 7 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 140 MG Daily Dose Carton]	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363410	4 {7 (cabozantinib 20 MG Oral Capsule [Cometriq]) / 7 (cabozantinib 80 MG Oral Capsule [Cometriq]) } Pack [Cometriq 100 MG Daily Dose Carton]	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363409	cabozantinib 100 MG Daily Dose Carton	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363409	cabozantinib 100 MG Daily Dose Carton Pack, 4 Blister Cards, 14 Capsules Each	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363312	cabozantinib 140 MG Daily Dose Carton	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363312	cabozantinib 140 MG Daily Dose Carton Pack, 4 Blister Cards, 28 Capsules Each	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363273	cabozantinib 20 MG (as cabozantinib s-malate 25 MG) Oral Capsule	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364580	cabozantinib 60 MG Daily Dose Carton	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364580	cabozantinib 60 MG Daily Dose Carton Pack, 4 Blister Cards, 21 Capsules Each	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363281	cabozantinib 80 MG (as cabozantinib s-malate 102 MG) Oral Capsule	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363410	Cometriq 100 MG Daily Dose Carton Pack	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363410	Cometriq 100 MG Daily Dose Carton Pack, 4 Blister Cards, 14 Capsules Each	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363408	Cometriq 140 MG Daily Dose Carton Pack	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363408	Cometriq 140 MG Daily Dose Carton Pack, 4 Blister Cards, 28 Capsules Each	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363279	Cometriq 20 MG Oral Capsule	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364581	Cometriq 60 MG Daily Dose Carton Pack	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1364581	Cometriq 60 MG Daily Dose Carton Pack, 4 Blister Cards, 21 Capsules Each	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16
1363284	Cometriq 80 MG Oral Capsule	SY	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42388-013-14	42388001314	4 BLISTER PACK in 1 CARTON (42388-013-14) / 21 CAPSULE in 1 BLISTER PACK	4 blister pack	2012-11-29	0000-00-00	No	No	Current