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  5. NDC Package Code: 13533-635-12 Gamastan

NDC Package 13533-635-12 Gamastan

Immune Globulin (human) Injection, Solution Intramuscular - 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:
13533-635-12
Package Description:
1 VIAL in 1 CARTON / 10 mL in 1 VIAL (13533-635-13)
Product Code:
13533-635
Proprietary Name:
Gamastan
Non-Proprietary Name:
Immune Globulin (human)
Substance Name:
Human Immunoglobulin G
Usage Information:
This medication is used to provide protection (antibodies) against certain virus infections (hepatitis A, measles, chickenpox, rubella) in people who have not been vaccinated or have not had the infection before. It is also used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a certain immune system problem (immunoglobulin deficiency). This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies), which help fight infections. Routine vaccination is usually the best way to protect against infection. Talk with your doctor about a recommended vaccination schedule.
11-Digit NDC Billing Format:
13533063512
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1809032 - immunoglobulin G, human 15-18 % in 2 ML Injection
  • RxCUI: 1809032 - 2 ML immunoglobulin G, human 180 MG/ML Injection
  • RxCUI: 1809032 - immunoglobulin G, human 15-18 % per 2 ML Injection
  • RxCUI: 1809034 - GamaSTAN 15-18 % in 2 ML Injection
  • RxCUI: 1809034 - 2 ML immunoglobulin G, human 180 MG/ML Injection [GamaSTAN]
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • HUMAN IMMUNOGLOBULIN G .165 g/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:
    BLA101134
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-14-1996
    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
    13533-635-041 VIAL in 1 CARTON / 2 mL in 1 VIAL (13533-635-40)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 13533-635-12?

    The NDC Packaged Code 13533-635-12 is assigned to a package of 1 vial in 1 carton / 10 ml in 1 vial (13533-635-13) of Gamastan, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection, solution and is administered via intramuscular form.

    Is NDC 13533-635 included in the NDC Directory?

    Yes, Gamastan with product code 13533-635 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on August 14, 1996 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 13533-635-12?

    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 13533-635-12?

    The 11-digit format is 13533063512. 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
    5-3-213533-635-125-4-213533-0635-12