Alphanine Kit
NDC Package 68516-3607-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Alphanine (coagulation factor ix (human)) kits is a medication used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). This formulation utilizes a kit delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 68516-3607 and is authorized under FDA application BLA103249.

Identification & Billing

NDC Package Code
68516-3607-2
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2)
Product Code
68516-3607
11-Digit Billing Format
68516360702
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alphanine SD
Non-Proprietary Name
Coagulation Factor Ix (human)
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intravenous - Administration within or into a vein or veins.
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 reverse the effects of "blood thinners" (e.g., warfarin). Most types of 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). If you are using this medication for one of these conditions, consult your doctor or pharmacist to make sure that you are using the right product.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA103249
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-31-1990
Listing Expiration
12-31-2026
Exclude Flag
N
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 68516-3607-2 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial (68516-3604-2) * 10 ml in 1 vial, single-dose (68516-1002-2) of Alphanine SD, a plasma derivative labeled by Grifols Usa, Llc. This kit is formulated for intravenous use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Grifols Usa, Llc on December 31, 1990. The current certification is valid through December 31, 2026.

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 reverse the effects of "blood thinners" (e.g., warfarin). Most types of 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). If you are using this medication for one of these conditions, consult your doctor or pharmacist to make sure that you are using the right product.

How is this Grifols Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68516360702. 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 (5-4-1)
68516-3607-2
11-Digit CMS (5-4-2)
68516-3607-02

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