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  5. NDC Package Code: 68516-4602-1 Alphanate

NDC Package 68516-4602-1 Alphanate

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
68516-4602-1
Package Description:
1 KIT in 1 CARTON * 5 mL in 1 VIAL (68516-4606-1) * 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-05)
Product Code:
68516-4602
Proprietary Name:
Alphanate
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:
68516460201
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Labeler Name:
Grifols Usa, Llc
Sample Package:
No
FDA Application Number:
BLA102475
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
08-15-1978
End Marketing Date:
02-28-2022
Listing Expiration Date:
02-28-2022
Exclude Flag:
D
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.

Frequently Asked Questions

What is NDC 68516-4602-1?

The NDC Packaged Code 68516-4602-1 is assigned to a package of 1 kit in 1 carton * 5 ml in 1 vial (68516-4606-1) * 5 ml in 1 vial, single-dose (63323-185-05) of Alphanate, labeled by Grifols Usa, Llc. The product's dosage form is and is administered via form.

Is NDC 68516-4602 included in the NDC Directory?

No, Alphanate with product code 68516-4602 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Grifols Usa, Llc on August 15, 1978 and its listing in the NDC Directory is set to expire on February 28, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 68516-4602-1?

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 68516-4602-1?

The 11-digit format is 68516460201. 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
5-4-168516-4602-15-4-268516-4602-01