Alphanate Kit
NDC Package 68516-4618-2

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

Package Information

Alphanate (antihemophilic factor/von willebrand factor complex (human)) kits is this product contains human factor VIII (also called antihemophilic factor) and von Willebrand factor complex. This formulation utilizes a kit delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 68516-4618 and is authorized under FDA application BLA102475.

Identification & Billing

NDC Package Code
68516-4618-2
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL (68516-4607-2) * 10 mL in 1 VIAL, GLASS (76297-002-12)
Product Code
68516-4618
11-Digit Billing Format
68516461802
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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]

Clinical Specifications

Proprietary Name
Alphanate
Non-Proprietary Name
Antihemophilic Factor/von Willebrand Factor Complex (human)
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intravenous - Administration within or into a vein or veins.
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.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA102475
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-15-1978
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7186
Source: ASP
Antihemophilic viii/vwf comp
HCPCS Dosage PER FACTOR VIII IU
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 68516-4618-2 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial (68516-4607-2) * 10 ml in 1 vial, glass (76297-002-12) of Alphanate, 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 August 15, 1978. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68516461802. 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)
68516-4618-2
11-Digit CMS (5-4-2)
68516-4618-02

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