NDC Package 82194-510-02 Vyjuvek

Kit - View Billable Units, 11-Digit Format, RxNorm

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:
82194-510-02
Package Description:
1 KIT in 1 CARTON * 1.5 mL in 1 VIAL (82194-001-01) * 1 mL in 1 VIAL (82194-501-01)
Product Code:
Proprietary Name:
Vyjuvek
Non-Proprietary Name:
Vyjuvek
Usage Information:
VYJUVEK is indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
11-Digit NDC Billing Format:
82194051002
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2637762 - beremagene geperpavec-svdt 5,000,000,000 PFU/ML Topical Suspension
  • RxCUI: 2637762 - beremagene geperpavec-svdt 5000000000 UNT/ML Topical Suspension
  • RxCUI: 2637762 - beremagene geperpavec-svdt 5,000,000,000 UNT/ML Topical Suspension
  • RxCUI: 2637767 - Vyjuvek 5,000,000,000 PFU/ML Topical Suspension
  • RxCUI: 2637767 - beremagene geperpavec-svdt 5000000000 UNT/ML Topical Suspension [Vyjuvek]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Krystal Biotech, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125774
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-19-2023
    Listing Expiration Date:
    12-31-2024
    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 82194-510-02?

    The NDC Packaged Code 82194-510-02 is assigned to a package of 1 kit in 1 carton * 1.5 ml in 1 vial (82194-001-01) * 1 ml in 1 vial (82194-501-01) of Vyjuvek, a human prescription drug labeled by Krystal Biotech, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 82194-510 included in the NDC Directory?

    Yes, Vyjuvek with product code 82194-510 is active and included in the NDC Directory. The product was first marketed by Krystal Biotech, Inc. on May 19, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 82194-510-02?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 82194-510-02?

    The 11-digit format is 82194051002. 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
    5-3-282194-510-025-4-282194-0510-02