vanflyta

Generic: quizartinib

Labeler: daiichi sankyo inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vanflyta
Generic Name quizartinib
Labeler daiichi sankyo inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

quizartinib dihydrochloride 17.7 mg/1

Manufacturer
Daiichi Sankyo Inc.

Identifiers & Regulatory

Product NDC 65597-504
Product ID 65597-504_f306ed98-2cbf-48c7-8b9d-b9dfc5eb91a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216993
Listing Expiration 2026-12-31
Marketing Start 2023-07-20

Pharmacologic Class

Classes
fms-like receptor tyrosine kinase 3 (flt3) inhibitors [moa] kinase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65597504
Hyphenated Format 65597-504

Supplemental Identifiers

RxCUI
2643054 2643060 2643062 2643064
UNII
WK7Q6ZIZ10

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vanflyta (source: ndc)
Generic Name quizartinib (source: ndc)
Application Number NDA216993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17.7 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65597-504-04) / 14 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65597-504-28) / 28 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

65597-504-04 1 BOTTLE in 1 CARTON (65597-504-04) / 14 TABLET, FILM COATED in 1 BOTTLE 65597-504-28 1 BOTTLE in 1 CARTON (65597-504-28) / 28 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

quizartinib dihydrochloride (17.7 mg/1)

Linked Drug Pages (1)

VANFLYTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f306ed98-2cbf-48c7-8b9d-b9dfc5eb91a6", "openfda": {"unii": ["WK7Q6ZIZ10"], "rxcui": ["2643054", "2643060", "2643062", "2643064"], "spl_set_id": ["29cdbcfe-497d-4e78-bb7b-2d4acafe8e86"], "manufacturer_name": ["Daiichi Sankyo Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65597-504-04)  / 14 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "65597-504-04", "marketing_start_date": "20230720"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65597-504-28)  / 28 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "65597-504-28", "marketing_start_date": "20230720"}], "brand_name": "VANFLYTA", "product_id": "65597-504_f306ed98-2cbf-48c7-8b9d-b9dfc5eb91a6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["FMS-like Receptor Tyrosine Kinase 3 (FLT3) Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "65597-504", "generic_name": "QUIZARTINIB", "labeler_name": "Daiichi Sankyo Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VANFLYTA", "active_ingredients": [{"name": "QUIZARTINIB DIHYDROCHLORIDE", "strength": "17.7 mg/1"}], "application_number": "NDA216993", "marketing_category": "NDA", "marketing_start_date": "20230720", "listing_expiration_date": "20261231"}