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  5. NDC Package Code: 49591-532-51 Cytogam

NDC Package 49591-532-51 Cytogam

Human Cytomegalovirus Immune Globulin Liquid Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
49591-532-51
Package Description:
1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS (49591-532-50)
Product Code:
49591-532
Proprietary Name:
Cytogam
Non-Proprietary Name:
Human Cytomegalovirus Immune Globulin
Substance Name:
Human Cytomegalovirus Immune Globulin
Usage Information:
This medication is used to prevent a certain serious viral infection (cytomegalovirus-CMV) in persons having an organ transplant (kidney, heart, liver, lung, pancreas). During the transplant process, the body's defense system (immune system) is weakened to prevent the body from attacking (rejecting) the new organ. A weakened immune system increases the risk of a serious, possibly fatal infection with CMV. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies) that help fight CMV. This medication is often used with the antiviral medication ganciclovir.
11-Digit NDC Billing Format:
49591053251
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 204528 - cytomegalovirus immune globulin, human 2.5 GM in 50 mL Injection
  • RxCUI: 204528 - 50 ML cytomegalovirus immune globulin, human 50 MG/ML Injection
  • RxCUI: 204528 - cytomegalovirus immune globulin, human 2.5 GM per 50 ML Injection
  • RxCUI: 204528 - cytomegalovirus immune globulin, human 2500 MG per 50 ML Injection
  • RxCUI: 209029 - Cytogam 2.5 GM in 50 ML Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Kamada Ltd.
    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 CYTOMEGALOVIRUS IMMUNE GLOBULIN 2500 mg/50mL
    • Pharmacologic Class(es):
  • Human Immunoglobulin G - [EPC] (Established Pharmacologic Class)
  • Immunoglobulins - [CS]
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
  • Virus Neutralization - [MoA] (Mechanism of Action)
  • Virus-specific Hyperimmune Globulins - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    BLA103189
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-01-2023
    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.

    Frequently Asked Questions

    What is NDC 49591-532-51?

    The NDC Packaged Code 49591-532-51 is assigned to a package of 1 vial, glass in 1 carton / 50 ml in 1 vial, glass (49591-532-50) of Cytogam, a plasma derivative labeled by Kamada Ltd.. The product's dosage form is liquid and is administered via intravenous form.

    Is NDC 49591-532 included in the NDC Directory?

    Yes, Cytogam with product code 49591-532 is active and included in the NDC Directory. The product was first marketed by Kamada Ltd. on June 01, 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 NDC billing unit for package 49591-532-51?

    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 49591-532-51?

    The 11-digit format is 49591053251. 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
    5-3-249591-532-515-4-249591-0532-51