Dexmedetomidine Hydrochloride Injection
NDC Package 66794-235-41

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

Package Information

Dexmedetomidine Hydrochloride injection is none. This formulation utilizes a injection delivery system. Marketed by Piramal Critical Care Inc, this product is identified by NDC 66794-235 and is authorized under FDA application ANDA209307.

Identification & Billing

NDC Package Code
66794-235-41
Package Description
10 VIAL in 1 CARTON / 100 mL in 1 VIAL (66794-235-02)
Product Code
66794-235
11-Digit Billing Format
66794023541
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 Hydrochloride
Non-Proprietary Name
Dexmedetomidine Hydrochloride
Substance Name
Dexmedetomidine Hydrochloride
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)
DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL
Pharmacologic Class
Usage Information
None.

Regulatory & Marketing

Labeler Name
Piramal Critical Care Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA209307
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2021
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 66794-235-41 identifies a specific commercial package of 10 vial in 1 carton / 100 ml in 1 vial (66794-235-02) of Dexmedetomidine Hydrochloride, a human prescription drug labeled by Piramal Critical Care Inc. This injection 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 Piramal Critical Care Inc on April 01, 2021. The current certification is valid through December 31, 2026.

How is this Piramal Critical Care Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66794023541. 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)
66794-235-41
11-Digit CMS (5-4-2)
66794-0235-41

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