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  4. 58394-001
  5. NDC Package Code: 58394-001-06 Benefix

NDC Package 58394-001-06 Benefix

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:
58394-001-06
Package Description:
1 KIT in 1 CARTON * 5 mL in 1 SYRINGE (58394-020-01) * 1 mL in 1 PACKET * 5 mL in 1 VIAL, SINGLE-USE (58394-101-06)
Product Code:
58394-001
Proprietary Name:
Benefix
Usage Information:
This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause. This medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).
11-Digit NDC Billing Format:
58394000106
Labeler Name:
Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
Sample Package:
No
FDA Application Number:
BLA103677
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
02-01-1997
End Marketing Date:
09-18-2015
Listing Expiration Date:
09-18-2015
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 58394-001-06?

The NDC Packaged Code 58394-001-06 is assigned to a package of 1 kit in 1 carton * 5 ml in 1 syringe (58394-020-01) * 1 ml in 1 packet * 5 ml in 1 vial, single-use (58394-101-06) of Benefix, labeled by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.. The product's dosage form is and is administered via form.

Is NDC 58394-001 included in the NDC Directory?

No, Benefix with product code 58394-001 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. on February 01, 1997 and its listing in the NDC Directory is set to expire on September 18, 2015 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58394-001-06?

The 11-digit format is 58394000106. 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
5-3-258394-001-065-4-258394-0001-06