NDC Package 13533-810-05 Xembify

Immune Globulin Subcutaneous,Human-klhw Solution Subcutaneous - 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:
13533-810-05
Package Description:
1 VIAL in 1 CARTON / 5 mL in 1 VIAL (13533-810-06)
Product Code:
Proprietary Name:
Xembify
Non-Proprietary Name:
Immune Globulin Subcutaneous, Human-klhw
Substance Name:
Human Immunoglobulin G
Usage Information:
XEMBIFY™ (immune globulin subcutaneous, human – klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.[1-4]
11-Digit NDC Billing Format:
13533081005
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2196292 - immune globulin subcutaneous (human) - klhw 20 % (1 GM per 5 ML) Injection
  • RxCUI: 2196292 - 5 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection
  • RxCUI: 2196297 - Xembify 20 % (1 GM in 5 ML) Injection
  • RxCUI: 2196297 - 5 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]
  • RxCUI: 2196297 - 5 ML Xembify 200 MG/ML Injection
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA125683
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-03-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    13533-810-101 VIAL in 1 CARTON / 10 mL in 1 VIAL (13533-810-11)
    13533-810-201 VIAL in 1 CARTON / 20 mL in 1 VIAL (13533-810-21)
    13533-810-501 VIAL in 1 CARTON / 50 mL in 1 VIAL (13533-810-51)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 13533-810-05?

    The NDC Packaged Code 13533-810-05 is assigned to a package of 1 vial in 1 carton / 5 ml in 1 vial (13533-810-06) of Xembify, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is solution and is administered via subcutaneous form.

    Is NDC 13533-810 included in the NDC Directory?

    Yes, Xembify with product code 13533-810 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on July 03, 2019 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 13533-810-05?

    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 13533-810-05?

    The 11-digit format is 13533081005. 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
    5-3-213533-810-055-4-213533-0810-05