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  5. NDC Package Code: 61476-104-20 Alyglo

NDC Package 61476-104-20 Alyglo

Human Immunoglobulin G Liquid Intravenous - 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:
61476-104-20
Package Description:
1 VIAL, GLASS in 1 CARTON / 200 mL in 1 VIAL, GLASS (61476-104-03)
Product Code:
61476-104
Proprietary Name:
Alyglo
Non-Proprietary Name:
Human Immunoglobulin G
Substance Name:
Human Immunoglobulin G
Usage Information:
ALYGLO (immune globulin intravenous, human-stwk) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID).
11-Digit NDC Billing Format:
61476010420
NDC to RxNorm Crosswalk:
  • RxCUI: 2672098 - immune globulin intravenous (human) - stwk 10 % in 50 ML Injection
  • RxCUI: 2672098 - 50 ML immune globulin intravenous (human) - stwk 100 MG/ML Injection
  • RxCUI: 2672098 - immune globulin intravenous (human) - stwk 10 % per 50 ML Injection
  • RxCUI: 2672098 - immune globulin intravenous (human) - stwk 100 MG/ML per 50 ML Injection
  • RxCUI: 2672098 - immune globulin intravenous (human) - stwk 5 GM per 50 ML Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Gc Biopharma Corp.
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • HUMAN IMMUNOGLOBULIN G 100 mg/mL
    • Pharmacologic Class(es):
  • Antigen Neutralization - [MoA] (Mechanism of Action)
  • Human Immunoglobulin G - [EPC] (Established Pharmacologic Class)
  • Immunoglobulins - [CS]
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BLA125743
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-15-2023
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61476-104-051 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS (61476-104-01)
    61476-104-101 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (61476-104-02)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61476-104-20?

    The NDC Packaged Code 61476-104-20 is assigned to a package of 1 vial, glass in 1 carton / 200 ml in 1 vial, glass (61476-104-03) of Alyglo, a plasma derivative labeled by Gc Biopharma Corp.. The product's dosage form is liquid and is administered via intravenous form.

    Is NDC 61476-104 included in the NDC Directory?

    Yes, Alyglo with product code 61476-104 is active and included in the NDC Directory. The product was first marketed by Gc Biopharma Corp. on December 15, 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 11-digit format for NDC 61476-104-20?

    The 11-digit format is 61476010420. 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
    5-3-261476-104-205-4-261476-0104-20