NDC Package 68516-4620-2 Alphanate

Antihemophilic Factor/von Willebrand Factor Complex (human) Kit Intravenous - 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:
68516-4620-2
Package Description:
1 KIT in 1 CARTON * 10 mL in 1 VIAL (68516-4610-2) * 10 mL in 1 VIAL, GLASS (76297-002-12)
Product Code:
Proprietary Name:
Alphanate
Non-Proprietary Name:
Antihemophilic Factor/von Willebrand Factor Complex (human)
Usage Information:
This product contains human factor VIII (also called antihemophilic factor) and von Willebrand factor complex. Factors are proteins normally found in the blood that help the blood to thicken (clot) and stop any bleeding. People with low levels of factor VIII and von Willebrand factor are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product is used to temporarily replace the missing factors and reduce bleeding. Different brands of this product have different amounts of these factors, and therefore different uses. These products are not interchangeable. Do not change brands of this medication without the approval of your doctor. Some products are used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). Some products are used to treat bleeding episodes in people with low levels of von Willebrand factor (von Willebrand disease) who do not respond to or cannot tolerate desmopressin. Some products are used to prevent excessive bleeding during and after surgery in patients with von Willebrand disease.
11-Digit NDC Billing Format:
68516462002
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1661332 - antihemophilic factor / von Willebrand factor complex, human 1 UNT Injection
  • RxCUI: 1661332 - factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection
  • RxCUI: 1661332 - factor VIII / von Willebrand Factor complex, human 1 UNT Injection
  • RxCUI: 1661345 - Alphanate (expressed as von Willebrand factor) 1 UNT Injection
  • RxCUI: 1661345 - factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Alphanate]
  • 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:
    BLA102475
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-26-2014
    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 68516-4620-2 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    68516462002J7186Antihemophilic viii/vwf compPER FACTOR VIII IU1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68516-4620-2?

    The NDC Packaged Code 68516-4620-2 is assigned to a package of 1 kit in 1 carton * 10 ml in 1 vial (68516-4610-2) * 10 ml in 1 vial, glass (76297-002-12) of Alphanate, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is kit and is administered via intravenous form.

    Is NDC 68516-4620 included in the NDC Directory?

    Yes, Alphanate with product code 68516-4620 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on June 26, 2014 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 68516-4620-2?

    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 68516-4620-2?

    The 11-digit format is 68516462002. 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
    5-4-168516-4620-25-4-268516-4620-02