Cytogam Liquid
NDC Package 49591-532-51

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cytogam (human cytomegalovirus immune globulin) liquids is a medication used to prevent a certain serious viral infection (cytomegalovirus-CMV) in persons having an organ transplant (kidney, heart, liver, lung, pancreas). This formulation utilizes a liquid delivery system. Marketed by Kamada Ltd., this product is identified by NDC 49591-532 and is authorized under FDA application BLA103189.

Identification & Billing

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
11-Digit Billing Format
49591053251
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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

Clinical Specifications

Proprietary Name
Cytogam
Non-Proprietary Name
Human Cytomegalovirus Immune Globulin
Substance Name
Human Cytomegalovirus Immune Globulin
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN 2500 mg/50mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Kamada Ltd.
Product Type
Plasma Derivative
FDA Application #
BLA103189
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-01-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49591-532-51 identifies a specific commercial 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.. This liquid is formulated for intravenous use and contains human cytomegalovirus immune globulin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kamada Ltd. on June 01, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Kamada Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49591053251. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49591-532-51
11-Digit CMS (5-4-2)
49591-0532-51

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.