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NDC 0069-2004 Beqvez

Fidanacogene Elaparvovec-dzkt Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0069-2004?
  4. Beqvez Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0069-2004
Proprietary Name:
Beqvez
Non-Proprietary Name: [1]
Fidanacogene Elaparvovec-dzkt
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Pfizer Laboratories Div Pfizer Inc
Labeler Code:
0069
Product Label ID:
5f477a47-bdc2-41fb-a720-30f9809dc6e8
FDA Application Number: [6]
BLA125786
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
05-02-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
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Product Details

What is NDC 0069-2004?

The NDC code 0069-2004 is assigned by the FDA to the product Beqvez which is a human prescription drug product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Beqvez is fidanacogene elaparvovec-dzkt. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0069-2004-04 1 carton in 1 carton / 1 kit in 1 carton (0069-2004-14) * 1 ml in 1 vial, single-dose (0069-0422-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Beqvez?

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)].

Which are Beqvez UNII Codes?

The UNII codes for the active ingredients in this product are:

  • FIDANACOGENE ELAPARVOVEC (UNII: 413EU9081Y)
  • FIDANACOGENE ELAPARVOVEC (UNII: 413EU9081Y) (Active Moiety)

Which are Beqvez Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Beqvez?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".