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  5. NDC Package Code: 0069-2004-04 Beqvez

NDC Package 0069-2004-04 Beqvez

Fidanacogene Elaparvovec-dzkt Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0069-2004-04
Package Description:
1 CARTON in 1 CARTON / 1 KIT in 1 CARTON (0069-2004-14) * 1 mL in 1 VIAL, SINGLE-DOSE (0069-0422-01)
Product Code:
0069-2004
Proprietary Name:
Beqvez
Non-Proprietary Name:
Fidanacogene Elaparvovec-dzkt
Usage Information:
BEQVEZ is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who:•Currently use factor IX prophylaxis therapy, or •Have current or historical life-threatening hemorrhage, or •Have repeated, serious spontaneous bleeding episodes, and, •Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.Select patients for therapy based on an FDA-approved companion diagnostic for BEQVEZ [see Dosage and Administration (2)].
11-Digit NDC Billing Format:
00069200404
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 2681026 - fidanacogene elaparvovec-dzkt 1.0 x 10(13) vg/ML in 1 ML Injection
  • RxCUI: 2681026 - 1 ML fidanacogene elaparvovec-dzkt 10000000000000 VECTOR-GENOMES/ML Injection
  • RxCUI: 2681026 - fidanacogene elaparvovec-dzkt 1.0 x 10(13) vg/ML per 1 ML Injection
  • RxCUI: 2681026 - fidanacogene elaparvovec-dzkt 10000000000000 VECTOR-GENOMES/ML per 1 ML Injection
  • RxCUI: 2681033 - BEQVEZ 1.0 x 10(13) vg/ML in 1 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pfizer Laboratories Div Pfizer Inc
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125786
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-02-2024
    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.

    Frequently Asked Questions

    What is NDC 0069-2004-04?

    The NDC Packaged Code 0069-2004-04 is assigned to a package of 1 carton in 1 carton / 1 kit in 1 carton (0069-2004-14) * 1 ml in 1 vial, single-dose (0069-0422-01) of Beqvez, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. The product's dosage form is kit and is administered via form.

    Is NDC 0069-2004 included in the NDC Directory?

    Yes, Beqvez with product code 0069-2004 is active and included in the NDC Directory. The product was first marketed by Pfizer Laboratories Div Pfizer Inc on May 02, 2024 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 0069-2004-04?

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

    What is the 11-digit format for NDC 0069-2004-04?

    The 11-digit format is 00069200404. 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 4-4-2 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
    4-4-20069-2004-045-4-200069-2004-04