Dexmedetomidine Hydrochloride Injection
NDC Package 71225-126-06

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

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Dexmedetomidine Hydrochloride injection is classified as a

administered via intravenous route. This formulation utilizes a injection delivery system. Marketed by Slayback Pharma Llc, this product is identified by NDC 71225-126 and is authorized under FDA application ANDA212791.

Identification & Billing

NDC Package Code
71225-126-06
Package Description
10 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE (71225-126-03)
Product Code
71225-126
11-Digit Billing Format
71225012606
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

Regulatory & Marketing

Labeler Name
Slayback Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212791
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-06-2019
End Marketing Date
07-31-2026
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 (71225-126). Click a package code to view its specific billing and regulatory data.

71225-126-04
10 VIAL in 1 CARTON / 20 mL in 1 VIAL (71225-126-01)
71225-126-05
20 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE (71225-126-02)

* 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 71225-126-06 identifies a specific commercial package of 10 bottle in 1 carton / 100 ml in 1 bottle (71225-126-03) of Dexmedetomidine Hydrochloride, a human prescription drug labeled by Slayback Pharma Llc. 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 Slayback Pharma Llc on December 06, 2019.

How is this Slayback Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71225012606. 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)
71225-126-06
11-Digit CMS (5-4-2)
71225-0126-06

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