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  5. NDC Package Code: 0053-8131-02 Helixate Fs

NDC Package 0053-8131-02 Helixate Fs

View Billable Units, 11-Digit Format, RxNorm

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 discontinued by the firm.

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:
0053-8131-02
Package Description:
1 KIT in 1 BOX * 2.5 mL in 1 VIAL, SINGLE-USE (0053-8141-01) * 2.5 mL in 1 VIAL (0053-7653-52)
Product Code:
0053-8131
Proprietary Name:
Helixate Fs
Usage Information:
This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.
11-Digit NDC Billing Format:
00053813102
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Labeler Name:
Csl Behring Llc
Sample Package:
No
FDA Application Number:
BLA103332
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
08-18-2000
End Marketing Date:
07-10-2020
Listing Expiration Date:
07-10-2020
Exclude Flag:
D
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 0053-8131-02?

The NDC Packaged Code 0053-8131-02 is assigned to a package of 1 kit in 1 box * 2.5 ml in 1 vial, single-use (0053-8141-01) * 2.5 ml in 1 vial (0053-7653-52) of Helixate Fs, labeled by Csl Behring Llc. The product's dosage form is and is administered via form.

Is NDC 0053-8131 included in the NDC Directory?

No, Helixate Fs with product code 0053-8131 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Csl Behring Llc on August 18, 2000 and its listing in the NDC Directory is set to expire on July 10, 2020 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0053-8131-02?

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 0053-8131-02?

The 11-digit format is 00053813102. 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 4-4-2 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
4-4-20053-8131-025-4-200053-8131-02