NDC Package 76179-010-04 Qivigy Kthm

Human Immunoglobulin G Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
76179-010-04
Package Description:
1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (76179-010-03)
Product Code:
Proprietary Name:
Qivigy Kthm
Non-Proprietary Name:
Human Immunoglobulin G
Substance Name:
Human Immunoglobulin G
11-Digit NDC Billing Format:
76179001004
Product Type:
Human Prescription Drug
Labeler Name:
Kedrion S.p.a.
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(s):
Intravenous - Administration within or into a vein or veins.
Sample Package:
No
FDA Application Number:
BLA125822
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
09-26-2025
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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
76179-010-021 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS (76179-010-01)

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Frequently Asked Questions

What is NDC 76179-010-04?

The NDC Packaged Code 76179-010-04 is assigned to a package of 1 vial, glass in 1 carton / 100 ml in 1 vial, glass (76179-010-03) of Qivigy Kthm, a human prescription drug labeled by Kedrion S.p.a.. The product's dosage form is injection, solution and is administered via intravenous form.

Is NDC 76179-010 included in the NDC Directory?

Yes, Qivigy Kthm with product code 76179-010 is active and included in the NDC Directory. The product was first marketed by Kedrion S.p.a. on September 26, 2025 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 76179-010-04?

The 11-digit format is 76179001004. 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
5-3-276179-010-045-4-276179-0010-04