NDC Package 58468-0348-1 Qfitlia

Fitusiran Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

58468-0348-1

Package Description:

1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE

Product Code:

58468-0348

Proprietary Name:

Qfitlia

Non-Proprietary Name:

Fitusiran

Substance Name:

Fitusiran

Usage Information:

QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.

11-Digit NDC Billing Format:

58468034801

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 2709452 - fitusiran 20 MG in 0.2 ML Injection
RxCUI: 2709452 - 0.2 ML fitusiran 100 MG/ML Injection
RxCUI: 2709452 - fitusiran 20 MG per 0.2 ML Injection
RxCUI: 2709458 - Qfitlia 20 MG in 0.2 ML Injection
RxCUI: 2709458 - 0.2 ML fitusiran 100 MG/ML Injection [Qfitlia]

Product Type:

Human Prescription Drug

Labeler Name:

Genzyme Corporation

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):

Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Active Ingredient(s):

FITUSIRAN 50 mg/.5mL

Sample Package:

FDA Application Number:

NDA219019

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

03-28-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

58468 - Genzyme Corporation
- 58468-0348 - Qfitlia
  - 58468-0348-1 - 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE

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 58468-0348-1?

The NDC Packaged Code 58468-0348-1 is assigned to a package of 1 syringe in 1 carton / .5 ml in 1 syringe of Qfitlia, a human prescription drug labeled by Genzyme Corporation. The product's dosage form is injection, solution and is administered via subcutaneous form.

Is NDC 58468-0348 included in the NDC Directory?

Yes, Qfitlia with product code 58468-0348 is active and included in the NDC Directory. The product was first marketed by Genzyme Corporation on March 28, 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 NDC billing unit for package 58468-0348-1?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 58468-0348-1?

The 11-digit format is 58468034801. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	58468-0348-1	5-4-2	58468-0348-01

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