Dexmedetomidine Hydrochloride Injection, Solution
NDC Package 63323-421-16

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

Package Information

Dexmedetomidine Hydrochloride injection is none. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-421 and is authorized under FDA application ANDA201072.

Identification & Billing

NDC Package Code
63323-421-16
Package Description
25 VIAL in 1 TRAY / 2 mL in 1 VIAL
Product Code
63323-421
11-Digit Billing Format
63323042116
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 309710 - dexmedeTOMIDine HCl 200 MCG in 2 ML Injection
  • RxCUI: 309710 - 2 ML dexmedetomidine 0.1 MG/ML Injection
  • RxCUI: 309710 - dexmedetomidine (as dexmedetomidine HCl) 0.1 MG/ML per 2 ML Injection
  • RxCUI: 309710 - dexmedetomidine (as dexmedetomidine HCl) 100 MCG/ML Injection

Clinical Specifications

Proprietary Name
Dexmedetomidine Hydrochloride
Non-Proprietary Name
Dexmedetomidine Hydrochloride
Substance Name
Dexmedetomidine Hydrochloride
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
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
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA201072
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-18-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63323-421). Click a package code to view its specific billing and regulatory data.

63323-421-02
25 VIAL in 1 TRAY / 2 mL in 1 VIAL (63323-421-01)

* 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 63323-421-16 identifies a specific commercial package of 25 vial in 1 tray / 2 ml in 1 vial of Dexmedetomidine Hydrochloride, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution 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 Fresenius Kabi Usa, Llc on September 18, 2015. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323042116. 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)
63323-421-16
11-Digit CMS (5-4-2)
63323-0421-16

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