Omisirge Kit
NDC Package 73441-800-04

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

Package Information

Omisirge (omidubicel-onlv) kits is oMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. This formulation utilizes a kit delivery system. Marketed by Gamida Cell Inc., this product is identified by NDC 73441-800 and is authorized under FDA application BLA125738.

Identification & Billing

NDC Package Code
73441-800-04
Package Description
1 KIT in 1 KIT * 10 mL in 1 BAG (73441-200-01) * 40 mL in 1 BAG (73441-400-01) * 20 mL in 1 BAG (73441-100-01) * 80 mL in 1 BAG (73441-300-01)
Product Code
73441-800
11-Digit Billing Format
73441080004
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Omisirge
Non-Proprietary Name
Omidubicel-onlv
Dosage Form
Kit - A packaged collection of related material.
Usage Information
OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Regulatory & Marketing

Labeler Name
Gamida Cell Inc.
Product Type
Cellular Therapy
FDA Application #
BLA125738
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-01-2023
Listing Expiration
12-31-2027
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 73441-800-04 identifies a specific commercial package of 1 kit in 1 kit * 10 ml in 1 bag (73441-200-01) * 40 ml in 1 bag (73441-400-01) * 20 ml in 1 bag (73441-100-01) * 80 ml in 1 bag (73441-300-01) of Omisirge, a cellular therapy labeled by Gamida Cell Inc.. This kit is formulated for use and contains 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 Gamida Cell Inc. on May 01, 2023. The current certification is valid through December 31, 2027.

How is this Gamida Cell Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73441080004. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
73441-800-04
11-Digit CMS (5-4-2)
73441-0800-04

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