Hemacord
NDC Package 76489-001-02

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hemacord is hPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. Marketed by New York Blood Center, this product is identified by NDC 76489-001 and is authorized under FDA application BLA125397.

Identification & Billing

NDC Package Code
76489-001-02
Package Description
1 BAG in 1 CANISTER / 25 mL in 1 BAG (76489-001-01)
Product Code
76489-001
11-Digit Billing Format
76489000102

Clinical Specifications

Proprietary Name
Hemacord
Dosage Form
-
Usage Information
HEMACORD, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells.

Regulatory & Marketing

Labeler Name
New York Blood Center
FDA Application #
BLA125397
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-10-2011
Listing Expiration
12-31-2024
Exclude Flag
I
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 76489-001-02 identifies a specific commercial package of 1 bag in 1 canister / 25 ml in 1 bag (76489-001-01) of Hemacord, labeled by New York Blood Center. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by New York Blood Center on November 10, 2011. The current certification is valid through December 31, 2024.

How is this New York Blood Center product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76489000102. 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)
76489-001-02
11-Digit CMS (5-4-2)
76489-0001-02

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