NDC Package 58394-635-03 Benefix

Coagulation Factor Ix (recombinant) Kit - View Billable Units, 11-Digit Format, RxNorm

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:
58394-635-03
Package Description:
1 KIT in 1 CARTON * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-135-03)
Product Code:
Proprietary Name:
Benefix
Non-Proprietary Name:
Coagulation Factor Ix (recombinant)
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:
58394063503
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1666311 - coagulation factor IX (recombinant human) 1 UNT Injection
  • RxCUI: 1666311 - nonacog alfa 1 UNT Injection
  • RxCUI: 1666317 - BeneFIX 1 UNT Injection
  • RxCUI: 1666317 - nonacog alfa 1 UNT Injection [BeneFIX]
  • RxCUI: 1666317 - BeneFIX (coagulation factor IX (recombinant human)) 1 UNT Injection
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    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
    Listing Expiration Date:
    12-31-2024
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 58394-635-03 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    58394063503J7195Factor ix recombinant nos1 IU1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58394-635-03?

    The NDC Packaged Code 58394-635-03 is assigned to a package of 1 kit in 1 carton * 5 ml in 1 syringe (58394-041-11) * 1 ml in 1 packet (0069-1111-01) * 5 ml in 1 vial, single-use (58394-135-03) of Benefix, a plasma derivative labeled by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc. The product's dosage form is kit and is administered via form.

    Is NDC 58394-635 included in the NDC Directory?

    Yes, Benefix with product code 58394-635 is active and included in the NDC Directory. The product was first marketed by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc on February 01, 1997 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 58394-635-03?

    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 58394-635-03?

    The 11-digit format is 58394063503. 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
    5-3-258394-635-035-4-258394-0635-03