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  5. NDC Package Code: 73441-800-04 Omisirge

NDC Package 73441-800-04 Omisirge

Omidubicel-onlv Kit - 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:
73441-800-04
Package Description:
1 KIT in 1 KIT * 80 mL in 1 BAG (73441-300-01) * 10 mL in 1 BAG (73441-200-01) * 40 mL in 1 BAG (73441-400-01) * 20 mL in 1 BAG (73441-100-01)
Product Code:
73441-800
Proprietary Name:
Omisirge
Non-Proprietary Name:
Omidubicel-onlv
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.
11-Digit NDC Billing Format:
73441080004
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 2637360 - omidubicel-onlv 800,000,000 CELLS in 100 ML Injection
  • RxCUI: 2637360 - 100 ML omidubicel-onlv 8000000 CELLS/ML Injection
  • RxCUI: 2637360 - omidubicel-onlv 800,000,000 CELLS per 100 ML Injection
  • RxCUI: 2637362 - omidubicel-onlv 400,000,000 CELLS in 50 ML Injection
  • RxCUI: 2637362 - 50 ML omidubicel-onlv 8000000 CELLS/ML Injection
    • Product Type:
    Cellular Therapy
    Labeler Name:
    Gamida Cell Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125738
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-01-2023
    Listing Expiration Date:
    12-31-2025
    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 73441-800-04?

    The NDC Packaged Code 73441-800-04 is assigned to a package of 1 kit in 1 kit * 80 ml in 1 bag (73441-300-01) * 10 ml in 1 bag (73441-200-01) * 40 ml in 1 bag (73441-400-01) * 20 ml in 1 bag (73441-100-01) of Omisirge, a cellular therapy labeled by Gamida Cell Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 73441-800 included in the NDC Directory?

    Yes, Omisirge with product code 73441-800 is active and included in the NDC Directory. The product was first marketed by Gamida Cell Inc. on May 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 73441-800-04?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 73441-800-04?

    The 11-digit format is 73441080004. 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
    5-3-273441-800-045-4-273441-0800-04