Dexmedetomidine Injection, Solution, Concentrate
NDC Package 44567-600-04

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

Package Information

Dexmedetomidine injection is none. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Wg Critical Care, Llc, this product is identified by NDC 44567-600 and is authorized under FDA application NDA206628.

Identification & Billing

NDC Package Code
44567-600-04
Package Description
4 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code
44567-600
11-Digit Billing Format
44567060004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dexmedetomidine
Non-Proprietary Name
Dexmedetomidine
Substance Name
Dexmedetomidine Hydrochloride
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL
Pharmacologic Class
Usage Information
None.

Regulatory & Marketing

Labeler Name
Wg Critical Care, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA206628
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-19-2016
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 44567-600-04 identifies a specific commercial package of 4 vial in 1 carton / 4 ml in 1 vial of Dexmedetomidine, a human prescription drug labeled by Wg Critical Care, Llc. This injection, solution, concentrate is formulated for intravenous use and contains dexmedetomidine hydrochloride 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 Wg Critical Care, Llc on April 19, 2016. The current certification is valid through December 31, 2027.

How is this Wg Critical Care, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44567060004. 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)
44567-600-04
11-Digit CMS (5-4-2)
44567-0600-04

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