Gohibic Injection
NDC Package 83000-110-04

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

Package Information

Gohibic (vilobelimab) injection is no contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA. This formulation utilizes a injection delivery system. Marketed by Inflarx Gmbh, this product is identified by NDC 83000-110.

Identification & Billing

NDC Package Code
83000-110-04
Package Description
4 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code
83000-110
11-Digit Billing Format
83000011004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gohibic
Non-Proprietary Name
Vilobelimab
Substance Name
Vilobelimab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
VILOBELIMAB 10 mg/mL
Usage Information
No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.

Regulatory & Marketing

Labeler Name
Inflarx Gmbh
Product Type
Human Prescription Drug
Marketing Category
EMERGENCY USE AUTHORIZATION -
Start Marketing Date
04-04-2023
Listing Expiration
12-31-2026
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 83000-110-04 identifies a specific commercial package of 4 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Gohibic, a human prescription drug labeled by Inflarx Gmbh. This injection is formulated for intravenous use and contains vilobelimab 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 Inflarx Gmbh on April 04, 2023. The current certification is valid through December 31, 2026.

How is this Inflarx Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83000011004. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
83000-110-04
11-Digit CMS (5-4-2)
83000-0110-04

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