Dexmedetomidine Hydrochloride Injection, Solution, Concentrate
NDC Package 36000-262-10

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, concentrate delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 36000-262 and is authorized under FDA application ANDA208103.

Identification & Billing

NDC Package Code
36000-262-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01)
Product Code
36000-262
11-Digit Billing Format
36000026210
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, 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
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA208103
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-16-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (36000-262). Click a package code to view its specific billing and regulatory data.

36000-262-05
5 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01)
36000-262-25
25 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (36000-262-01)

* 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 36000-262-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose (36000-262-01) of Dexmedetomidine Hydrochloride, a human prescription drug labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on April 16, 2026. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36000026210. 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)
36000-262-10
11-Digit CMS (5-4-2)
36000-0262-10

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