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  5. NDC Package Code: 61476-104-10 Alyglo

NDC Package 61476-104-10 Alyglo

Human Immunoglobulin G Liquid Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
61476-104-10
Package Description:
1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (61476-104-02)
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:
61476010410
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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):
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:
12-31-2025
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.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 61476-104-10 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
61476010410J1552Inj, alyglo, 500 mg500 MG10012020

* 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)
61476-104-201 VIAL, GLASS in 1 CARTON / 200 mL in 1 VIAL, GLASS (61476-104-03)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61476-104-10?

The NDC Packaged Code 61476-104-10 is assigned to a package of 1 vial, glass in 1 carton / 100 ml in 1 vial, glass (61476-104-02) 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, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61476-104-10?

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 61476-104-10?

The 11-digit format is 61476010410. 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
5-3-261476-104-105-4-261476-0104-10