Riastap Injection, Solution
NDC Package 63833-892-51

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

Package Information

Riastap (fibrinogen human) injection is riaSTAP®, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. This formulation utilizes a injection, solution delivery system. Marketed by Csl Behring Gmbh, this product is identified by NDC 63833-892 and is authorized under FDA application BLA125317.

Identification & Billing

NDC Package Code
63833-892-51
Package Description
1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (63833-892-90)
Product Code
63833-892
11-Digit Billing Format
63833089251
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Riastap
Non-Proprietary Name
Fibrinogen Human
Substance Name
Fibrinogen Human
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
FIBRINOGEN HUMAN 2600 mg/100mL
Pharmacologic Class
Usage Information
RiaSTAP®, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Regulatory & Marketing

Labeler Name
Csl Behring Gmbh
Product Type
Plasma Derivative
FDA Application #
BLA125317
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-16-2009
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63833-892-51 identifies a specific commercial package of 1 vial, glass in 1 carton / 100 ml in 1 vial, glass (63833-892-90) of Riastap, a plasma derivative labeled by Csl Behring Gmbh. This injection, solution is formulated for subcutaneous use and contains fibrinogen human 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 Csl Behring Gmbh on January 16, 2009. The current certification is valid through December 31, 2027.

How is this Csl Behring Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63833089251. 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 (5-3-2)
63833-892-51
11-Digit CMS (5-4-2)
63833-0892-51

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