Home NDC 80739-812 KRAZATI
Product NDC 80739-812
11-digit product format 807390812
Labeler code 80739
Product ID 80739-812_65724d4c-78ab-4d85-83b5-73b9da5c2cc3
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 43 .
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 2026-09-14 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 · 60 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 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…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216340-001 10689377 2037-05-17 U-3490 Drug substance, Drug product 2022-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216340-001 10689377 2037-05-17 U-3953 Drug substance, Drug product 2022-12-20 d06236e962d9…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 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 80739-812-18 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 80739-812-18 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
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 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