Home NDC 80739-812 KRAZATI
Product NDC 80739-812
11-digit product format 807390812
Labeler code 80739
Product ID 80739-812_a43d9052-415b-4293-a1c2-8638e222f04a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adagrasib
Dosage form TABLET, COATED
Route ORAL
Labeler Mirati Therapeutics, Inc
Application NDA216340
Marketing category NDA
Marketing start 2022-12-12
Substance ADAGRASIB
Active strength 200 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216340-001 KRAZATI ADAGRASIB 200MG TABLET / ORAL RLD, RS 2022-12-12
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 N216340-001 12653789 2043-08-21 Drug product 2026-07-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216340-001 NCE 2027-12-12 N216340-001 ODE-352 2029-12-12
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.
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 2026-11-14 07:37:17 2026-10 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216340-001 KRAZATI 200MG TABLET / ORAL RLD, RS 2022-12-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-11-14 07:37:17 2026-10 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N216340-001 12653789 2043-08-21 Drug product 2026-07-10 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216340-001 12653789 2043-08-21 Drug product 2026-07-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216340-001 12653789 2043-08-21 Drug product 2026-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216340-001 12653789 2043-08-21 Drug product 2026-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216340-001 12383503 2043-08-21 Drug product 2025-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216340-001 12336995 2041-02-05 U-3953 2025-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216340-001 12281113 2041-09-10 Drug substance, Drug product 2025-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 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 KRAZATI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADAGRASIB 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8EOO6HQF8Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2625917 Internal RxNorm lookup 2625923 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 80739-812-12 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-12 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-12 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-12 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-08-21 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-12 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-12 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-12 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-12 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022 80739-812-18 2025-07-29 These highlights do not include all the information needed to use KRAZATI safely and effectively. See full prescribing information for KRAZATI. KRAZATI ® (adagrasib) tablets, for oral use Initial U.S. Approval: 2022
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80739-812-12 KRAZATI 1 in 1 CARTON TABLET, COATED 1 13 80739-812-12 KRAZATI 120 in 1 BOTTLE TABLET, COATED 120 13 80739-812-18 KRAZATI 1 in 1 CARTON TABLET, COATED 1 13 80739-812-18 KRAZATI 180 in 1 BOTTLE TABLET, COATED 180 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80739-812 KRAZATI (ADAGRASIB) TABLET, COATED [MIRATI THERAPEUTICS, INC] 10 Current NDC, Legacy NDC, 4 package rows 20250119_0b8bf078-34c2-4f45-9012-38a8ac082b01.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80739-812-12 80739081212 1 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE 1 bottle 2022-12-12 0000-00-00 No No Current 80739-812-18 80739081218 1 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLE 1 bottle 2022-12-12 0000-00-00 No No Current