FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
KRAZATI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAGRASIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8EOO6HQF8Y
Rxcui2625917, 2625923

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ab1ea0-9c24-4df7-9bc5-68c995a25c03Product name120240205
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80739-812-122025-08-21C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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
80739-812-122025-08-21C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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
80739-812-182025-08-21C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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
80739-812-182025-08-21C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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
80739-812-122025-07-29C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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
80739-812-122025-07-29C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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
80739-812-182025-07-29C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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
80739-812-182025-07-29C16284748780-13b156c62-2a19-fb37-e063-e6dba90a4e07These 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 NDCProductDescriptionFormQuantityStrengthSPL version
80739-812-12KRAZATI1 in 1 CARTONTABLET, COATED113
80739-812-12KRAZATI120 in 1 BOTTLETABLET, COATED12013
80739-812-18KRAZATI1 in 1 CARTONTABLET, COATED113
80739-812-18KRAZATI180 in 1 BOTTLETABLET, COATED18013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80739-812-18EA - Each80739-81216420b80-d2a0-4b92-96d1-3effc34998ac12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80739-812KRAZATI (ADAGRASIB) TABLET, COATED [MIRATI THERAPEUTICS, INC]10Current NDC, Legacy NDC, 4 package rows20250119_0b8bf078-34c2-4f45-9012-38a8ac082b01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2625917adagrasib 200 MG Oral TabletPSN0b8bf078-34c2-4f45-9012-38a8ac082b0113
2625923KRAZATI 200 MG Oral TabletPSN0b8bf078-34c2-4f45-9012-38a8ac082b0113
2625923adagrasib 200 MG Oral Tablet [Krazati]SBD0b8bf078-34c2-4f45-9012-38a8ac082b0113
2625917adagrasib 200 MG Oral TabletSCD0b8bf078-34c2-4f45-9012-38a8ac082b0113
2625923Krazati 200 MG Oral TabletSY0b8bf078-34c2-4f45-9012-38a8ac082b0113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80739-812-12807390812121 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE1 bottle2022-12-120000-00-00NoNoCurrent
80739-812-18807390812181 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLE1 bottle2022-12-120000-00-00NoNoCurrent