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  5. NDC Package Code: 68982-349-02 Fibryga

NDC Package 68982-349-02 Fibryga

Fibrinogen (human) Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
68982-349-02
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS (68982-349-82)
Product Code:
68982-349
Proprietary Name:
Fibryga
Non-Proprietary Name:
Fibrinogen (human)
Substance Name:
Fibrinogen Human
Usage Information:
FIBRYGA is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to FIBRYGA or its components (Sodium Citrate Dihydrate; Glycine; L-Arginine Hydrochloride).
11-Digit NDC Billing Format:
68982034902
NDC to RxNorm Crosswalk:
Product Type:
Plasma Derivative
Labeler Name:
Octapharma Usa Inc
Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
FIBRINOGEN HUMAN 20 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
BLA125612
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
12-20-2024
Listing Expiration Date:
12-31-2026
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
68982-349-011 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS (68982-349-81)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68982-349-02?

The NDC Packaged Code 68982-349-02 is assigned to a package of 1 bottle, glass in 1 carton / 100 ml in 1 bottle, glass (68982-349-82) of Fibryga, a plasma derivative labeled by Octapharma Usa Inc. The product's dosage form is powder, for solution and is administered via intravenous form.

Is NDC 68982-349 included in the NDC Directory?

Yes, Fibryga with product code 68982-349 is active and included in the NDC Directory. The product was first marketed by Octapharma Usa Inc on December 20, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68982-349-02?

The 11-digit format is 68982034902. 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 5-3-2 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
5-3-268982-349-025-4-268982-0349-02