1. Home
  2. Labeler Index
  3. Grifols Usa, Llc
  4. 68516-3607
  5. NDC Package Code: 68516-3607-2 Alphanine SD

NDC Package 68516-3607-2 Alphanine SD

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

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

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:
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
Proprietary Name:
Alphanine SD
Non-Proprietary Name:
Coagulation Factor Ix (human)
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.
11-Digit NDC Billing Format:
68516360702
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1666303 - factor IX, human 1 UNT Injection
  • RxCUI: 1666303 - coagulation factor IX, human 1 UNT Injection
  • RxCUI: 1666309 - AlphaNine SD 1 UNT Injection
  • RxCUI: 1666309 - coagulation factor IX, human 1 UNT Injection [Alphanine SD]
  • RxCUI: 1666309 - Alphanine SD 1 UNT Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Sample Package:
    No
    FDA Application Number:
    BLA103249
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-31-1990
    Listing Expiration Date:
    12-31-2025
    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 68516-3607-2 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    68516360702J7193Factor ix non-recombinant1 IU1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68516-3607-2?

    The NDC Packaged Code 68516-3607-2 is assigned to a 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. The product's dosage form is kit and is administered via intravenous form.

    Is NDC 68516-3607 included in the NDC Directory?

    Yes, Alphanine SD with product code 68516-3607 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on December 31, 1990 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68516-3607-2?

    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 68516-3607-2?

    The 11-digit format is 68516360702. 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 5-4-1 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
    5-4-168516-3607-25-4-268516-3607-02