1. Labeler Index
  2. Kedrion Biopharma, Inc.
  3. 76125-900
  4. NDC Package Code: 76125-900-20 Gammaked

NDC Package 76125-900-20 Gammaked

Immune Globulin (human) Injection Intravenous; Subcutaneous - 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:
76125-900-20
Package Description:
1 VIAL, GLASS in 1 CARTON / 200 mL in 1 VIAL, GLASS (76125-900-21)
Product Code:
76125-900
Proprietary Name:
Gammaked
Non-Proprietary Name:
Immune Globulin (human)
Substance Name:
Human Immunoglobulin G
Usage Information:
This medication is used in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This medication is made from human blood that has a high level of antibodies which help fight infections. This product is also used to increase the number of certain blood cells (platelets) in people with a certain blood disorder (idiopathic thrombocytopenic purpura-ITP). Platelets are needed to stop bleeding and to form normal blood clots. In addition, this medication is used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps to improve these symptoms and prevents relapse.
11-Digit NDC Billing Format:
76125090020
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1809414 - immunoglobulin G, human 10 % in 50 ML Injection
  • RxCUI: 1809414 - 50 ML immunoglobulin G, human 100 MG/ML Injection
  • RxCUI: 1809414 - immunoglobulin G, human 10 % per 50 ML Injection
  • RxCUI: 1809414 - immunoglobulin G, human 5 GM per 50 ML Injection
  • RxCUI: 1809421 - immunoglobulin G, human 10 % in 100 ML Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Kedrion Biopharma, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • HUMAN IMMUNOGLOBULIN G 10 g/100mL
    • 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:
    BLA125046
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-13-2010
    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.

    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 76125-900-20 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    76125090020J1561Gamunex-c/gammaked500 MG20014040

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    76125-900-011 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS (76125-900-02)
    76125-900-101 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (76125-900-11)
    76125-900-251 VIAL, GLASS in 1 CARTON / 25 mL in 1 VIAL, GLASS (76125-900-26)
    76125-900-501 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS (76125-900-51)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76125-900-20?

    The NDC Packaged Code 76125-900-20 is assigned to a package of 1 vial, glass in 1 carton / 200 ml in 1 vial, glass (76125-900-21) of Gammaked, a plasma derivative labeled by Kedrion Biopharma, Inc.. The product's dosage form is injection and is administered via intravenous; subcutaneous form.

    Is NDC 76125-900 included in the NDC Directory?

    Yes, Gammaked with product code 76125-900 is active and included in the NDC Directory. The product was first marketed by Kedrion Biopharma, Inc. on October 13, 2010 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 76125-900-20?

    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 76125-900-20?

    The 11-digit format is 76125090020. 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
    5-3-276125-900-205-4-276125-0900-20