FDA.reportPublic FDA data

VANFLYTA

Product NDC
65597-504
11-digit product format
655970504
Labeler code
65597
Product ID
65597-504_ee05ebbe-cace-4b2f-bb89-c26687c1eeaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUIZARTINIB
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA216993
Marketing category
NDA
Marketing start
2023-07-20
Substance
QUIZARTINIB DIHYDROCHLORIDE
Active strength
17.7 mg/1
Pharmacologic classes
FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUIZARTINIB DIHYDROCHLORIDE17.7 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK7Q6ZIZ10
Rxcui2643054, 2643060, 2643062, 2643064

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a580eff-51ac-43d3-82ee-327c05875b59Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65597-504-042024-02-05C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-042024-02-05C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-042024-02-05C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-282024-02-05C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-282024-02-05C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-282024-02-05C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-042024-01-30C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-042024-01-30C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-042024-01-30C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-282024-01-30C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-282024-01-30C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
65597-504-282024-01-30C16284748780-11030e365-0196-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA ® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65597-504-04VANFLYTA14 in 1 BOTTLETABLET, FILM COATED1411
65597-504-04VANFLYTA1 in 1 CARTONTABLET, FILM COATED111
65597-504-28VANFLYTA1 in 1 CARTONTABLET, FILM COATED111
65597-504-28VANFLYTA28 in 1 BOTTLETABLET, FILM COATED2811

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-504-04EA - Each65597-50489a93c88-08cc-4f0a-8713-665d4d838ded12023-08-08
65597-504-28EA - Each65597-5048211fe88-1bcf-4d0f-b727-9c42e5a0fb7c12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65597-504VANFLYTA (QUIZARTINIB) TABLET, FILM COATED [DAIICHI SANKYO INC.]8Current NDC, 4 package rows20240709_29cdbcfe-497d-4e78-bb7b-2d4acafe8e86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2643054quizartinib 17.7 MG Oral TabletPSN29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643062quizartinib 26.5 MG Oral TabletPSN29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643060VANFLYTA 17.7 MG Oral TabletPSN29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643064VANFLYTA 26.5 MG Oral TabletPSN29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643060quizartinib 17.7 MG Oral Tablet [Vanflyta]SBD29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643064quizartinib 26.5 MG Oral Tablet [Vanflyta]SBD29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643054quizartinib 17.7 MG Oral TabletSCD29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643062quizartinib 26.5 MG Oral TabletSCD29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643054quizartinib 17.7 MG (equivalent to 20 MG quizartinib dihydrochloride) Oral TabletSY29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643062quizartinib 26.5 MG (equivalent to 30 MG quizartinib dihydrochloride) Oral TabletSY29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643060Vanflyta 17.7 MG (equivalent to 20 MG quizartinib dihydrochloride) Oral TabletSY29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643060Vanflyta 17.7 MG Oral TabletSY29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643064Vanflyta 26.5 MG (equivalent to 30 MG quizartinib dihydrochloride) Oral TabletSY29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611
2643064Vanflyta 26.5 MG Oral TabletSY29cdbcfe-497d-4e78-bb7b-2d4acafe8e8611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65597-504-04655970504041 BOTTLE in 1 CARTON (65597-504-04) / 14 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-20NoNoHistorical
65597-504-28655970504281 BOTTLE in 1 CARTON (65597-504-28) / 28 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-20NoNoHistorical