Precedex Injection, Solution, Concentrate
NDC Package 0404-9938-02

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

Package Information

Precedex (dexmedetomidine hydrochloride) injection is 1.1 Intensive Care Unit SedationPrecedex™ is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9938 and is authorized under FDA application NDA021038.

Identification & Billing

NDC Package Code
0404-9938-02
Package Description
1 VIAL in 1 BAG / 2 mL in 1 VIAL
Product Code
0404-9938
11-Digit Billing Format
00404993802
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Precedex
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
1.1 Intensive Care Unit SedationPrecedex™ is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours.Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.1.2 Procedural SedationPrecedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021038
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-13-2022
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 0404-9938-02 identifies a specific commercial package of 1 vial in 1 bag / 2 ml in 1 vial of Precedex, a human prescription drug labeled by Henry Schein, Inc.. 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 Henry Schein, Inc. on January 13, 2022. The current certification is valid through December 31, 2027.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404993802. 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 (4-4-2)
0404-9938-02
11-Digit CMS (5-4-2)
00404-9938-02

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