Benefix
NDC Package 58394-003-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Benefix is a medication used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Marketed by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc., this product is identified by NDC 58394-003 and is authorized under FDA application BLA103677.

Identification & Billing

NDC Package Code
58394-003-06
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 (58394-103-06)
Product Code
11-Digit Billing Format
58394000306

Clinical Specifications

Proprietary Name
Benefix
Dosage Form
-
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).

Regulatory & Marketing

Labeler Name
Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
FDA Application #
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
09-18-2015
Exclude Flag
D
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 58394-003-06 identifies a specific commercial 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 (58394-103-06) of Benefix, labeled by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.. 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 Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. on February 01, 1997. The current certification is valid through September 18, 2015.

What are the primary indications for this medication?

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).

How is this Wyeth Biopharma Division Of Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58394000306. 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)
58394-003-06
11-Digit CMS (5-4-2)
58394-0003-06

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