Alphanate Kit
NDC Package 68516-4613-2
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 68516-4613 and is authorized under FDA application BLA102475.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 68516 - Grifols Usa, Llc
- 68516-4613 - Alphanate
- 68516-4613-2 - 1 KIT in 1 CARTON * 10 mL in 1 VIAL (68516-4607-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2)
- 68516-4613 - Alphanate
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 68516-4613-2 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial (68516-4607-2) * 10 ml in 1 vial, single-dose (68516-1002-2) 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: 68516461302. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.