Eloctate
NDC Package 64406-809-01

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.

Eloctate is a medication used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). Marketed by Biogen Inc., this product is identified by NDC 64406-809 and is authorized under FDA application BLA125487.

Identification & Billing

NDC Package Code
64406-809-01
Package Description
1 KIT in 1 KIT * 3 mL in 1 VIAL (64406-491-08) * 3 mL in 1 VIAL (64406-035-01)
Product Code
11-Digit Billing Format
64406080901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Eloctate
Dosage Form
-
Usage Information
This medication is used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury. People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A. This medication should not be used to treat von Willebrand disease.

Regulatory & Marketing

Labeler Name
Biogen Inc.
FDA Application #
BLA125487
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-14-2014
End Marketing Date
04-30-2020
Listing Expiration
04-30-2020
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 64406-809-01 identifies a specific commercial package of 1 kit in 1 kit * 3 ml in 1 vial (64406-491-08) * 3 ml in 1 vial (64406-035-01) of Eloctate, labeled by Biogen 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 Biogen Inc. on July 14, 2014. The current certification is valid through April 30, 2020.

What are the primary indications for this medication?

This medication is used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury. People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A. This medication should not be used to treat von Willebrand disease.

How is this Biogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64406080901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
64406-809-01
11-Digit CMS (5-4-2)
64406-0809-01

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