Home NDC 42388-025-46 CABOMETYX
Product NDC 42388-025
Requested package NDC 42388-025-46
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 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42388-025 42388-025-46 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42388-025 42388-025-46 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42388-025 42388-025-46 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208692-001 CABOMETYX CABOZANTINIB S-MALATE EQ 20MG BASE TABLET / ORAL AB RLD 2016-04-25 N208692-002 CABOMETYX CABOZANTINIB S-MALATE EQ 40MG BASE TABLET / ORAL AB RLD 2016-04-25 N208692-003 CABOMETYX CABOZANTINIB S-MALATE EQ 60MG BASE TABLET / ORAL AB RLD, RS 2016-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 60 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 9 matching rows.
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 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL AB RLD 2016-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL AB RLD 2016-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL AB RLD, RS 2016-04-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208692-002 CABOMETYX EQ 40MG BASE TABLET / ORAL RLD 2016-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208692-003 CABOMETYX EQ 60MG BASE TABLET / ORAL RLD, RS 2016-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208692-001 CABOMETYX EQ 20MG BASE TABLET / ORAL RLD 2016-04-25 301d65b070ca…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 48 · 1,902 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 N208692-001 7579473 2026-08-14 Drug substance, Drug product 2016-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11091439 2030-01-15 Drug substance 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11091440 2030-01-15 Drug product 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11098015 2030-01-15 U-4131 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11098015 2030-01-15 U-4156 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11098015 2030-01-15 U-2488 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11098015 2030-01-15 U-1220 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11098015 2030-01-15 U-1480 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11098015 2030-01-15 U-3225 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 8877776 2030-10-08 U-3225 Drug substance, Drug product 2016-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 10034873 2031-07-18 U-2488 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 10039757 2031-07-18 U-1480 2018-09-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 11298349 2032-02-10 Drug product 2022-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 12128039 2032-02-10 U-1220 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 12128039 2032-02-10 U-1480 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 12128039 2032-02-10 U-2488 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 12128039 2032-02-10 U-3225 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 12128039 2032-02-10 U-4131 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 12128039 2032-02-10 U-4156 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-001 9724342 2033-07-09 Drug product 2017-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 7579473 2026-08-14 Drug substance, Drug product 2016-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11091439 2030-01-15 Drug substance 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11091440 2030-01-15 Drug product 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11098015 2030-01-15 U-4156 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11098015 2030-01-15 U-4131 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11098015 2030-01-15 U-2488 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11098015 2030-01-15 U-1220 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11098015 2030-01-15 U-1480 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11098015 2030-01-15 U-3225 2021-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 8877776 2030-10-08 U-3225 Drug substance, Drug product 2016-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 10034873 2031-07-18 U-2488 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 10039757 2031-07-18 U-1480 2018-09-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 11298349 2032-02-10 Drug product 2022-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 12128039 2032-02-10 U-1220 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 12128039 2032-02-10 U-1480 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 12128039 2032-02-10 U-2488 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 12128039 2032-02-10 U-3225 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 12128039 2032-02-10 U-4156 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 12128039 2032-02-10 U-4131 Drug product 2024-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208692-002 9724342 2033-07-09 Drug product 2017-08-25 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 13 · 489 observed states.
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 CABOMETYX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CABOZANTINIB S-MALATE 40 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790161 Internal RxNorm lookup 1790167 Internal RxNorm lookup 1790169 Internal RxNorm lookup 1790171 Internal RxNorm lookup 1790173 Internal RxNorm lookup 1790175 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 42388-025-26 2025-02-04 These 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 42388-025-26 2025-02-04 These 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 42388-025-37 2025-02-04 These 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 42388-025-37 2025-02-04 These 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 42388-025-46 2025-02-04 These 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 42388-025-46 2025-02-04 These 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 42388-025-57 2025-02-04 These 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 42388-025-57 2025-02-04 These 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 42388-025-26 2025-01-30 These 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 42388-025-26 2025-01-30 These 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 42388-025-37 2025-01-30 These 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 42388-025-37 2025-01-30 These 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 42388-025-46 2025-01-30 These 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 42388-025-46 2025-01-30 These 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 42388-025-57 2025-01-30 These 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 42388-025-57 2025-01-30 These 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42388-025 CABOMETYX (CABOZANTINIB) TABLET [EXELIXIS, INC.] 16 Current NDC, Legacy NDC, 6 package rows 20250406_3850cce2-6137-42e5-a792-d318c4a4b3b5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42388-025-46 42388002546 1 BOTTLE in 1 CARTON (42388-025-46) / 30 TABLET in 1 BOTTLE 1 bottle 2023-01-09 No No Current