Dexmedetomidine Hydrochloride Injection, Solution
NDC Package 43598-976-58

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 dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. This formulation utilizes a injection, solution delivery system. Marketed by Dr.reddy's Laboratories Inc, this product is identified by NDC 43598-976 and is authorized under FDA application ANDA209307.

Identification & Billing

NDC Package Code
43598-976-58
Package Description
10 VIAL in 1 CARTON / 50 mL in 1 VIAL (43598-976-11)
Product Code
43598-976
11-Digit Billing Format
43598097658
RxNorm Crosswalk

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 4 ug/mL
Pharmacologic Class
Usage Information
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours.Dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation.

Regulatory & Marketing

Labeler Name
Dr.reddy's Laboratories 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
08-17-2020
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 43598-976-58 identifies a specific commercial package of 10 vial in 1 carton / 50 ml in 1 vial (43598-976-11) of Dexmedetomidine Hydrochloride, a human prescription drug labeled by Dr.reddy's Laboratories Inc. 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 Dr.reddy's Laboratories Inc on August 17, 2020. The current certification is valid through December 31, 2026.

How is this Dr.reddy's Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598097658. 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)
43598-976-58
11-Digit CMS (5-4-2)
43598-0976-58

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