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  5. NDC Package Code: 65597-504-28 Vanflyta

NDC Package 65597-504-28 Vanflyta

Quizartinib Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65597-504-28
Package Description:
1 BOTTLE in 1 CARTON / 28 TABLET, FILM COATED in 1 BOTTLE
Product Code:
65597-504
Proprietary Name:
Vanflyta
Non-Proprietary Name:
Quizartinib
Substance Name:
Quizartinib Dihydrochloride
Usage Information:
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14)].
11-Digit NDC Billing Format:
65597050428
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2643054 - quizartinib 17.7 MG Oral Tablet
  • RxCUI: 2643054 - quizartinib 17.7 MG (equivalent to 20 MG quizartinib dihydrochloride) Oral Tablet
  • RxCUI: 2643060 - VANFLYTA 17.7 MG Oral Tablet
  • RxCUI: 2643060 - quizartinib 17.7 MG Oral Tablet [Vanflyta]
  • RxCUI: 2643060 - Vanflyta 17.7 MG (equivalent to 20 MG quizartinib dihydrochloride) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Daiichi Sankyo Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA216993
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-20-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65597-504-041 BOTTLE in 1 CARTON / 14 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65597-504-28?

    The NDC Packaged Code 65597-504-28 is assigned to a package of 1 bottle in 1 carton / 28 tablet, film coated in 1 bottle of Vanflyta, a human prescription drug labeled by Daiichi Sankyo Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 65597-504 included in the NDC Directory?

    Yes, Vanflyta with product code 65597-504 is active and included in the NDC Directory. The product was first marketed by Daiichi Sankyo Inc. on July 20, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65597-504-28?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 65597-504-28?

    The 11-digit format is 65597050428. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265597-504-285-4-265597-0504-28