Duraclon Injection, Solution
NDC Package 67457-218-10

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

Package Information

Duraclon (clonidine hydrochloride) injection is clonidine is used with another medication (an opioid) to treat severe pain in people with cancer. This formulation utilizes a injection, solution delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-218 and is authorized under FDA application NDA020615.

Identification & Billing

NDC Package Code
67457-218-10
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
67457-218
11-Digit Billing Format
67457021810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Duraclon
Non-Proprietary Name
Clonidine Hydrochloride
Substance Name
Clonidine 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
Epidural - Administration upon or over the dura mater.
Active Ingredient(s)
CLONIDINE HYDROCHLORIDE .1 mg/mL
Pharmacologic Class
Usage Information
Clonidine is used with another medication (an opioid) to treat severe pain in people with cancer. Clonidine belongs to a class of drugs known as central alpha agonists. It works by blocking the nerves in the spinal cord that send pain signals.

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020615
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-26-1997
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 67457-218-10 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Duraclon, a human prescription drug labeled by Mylan Institutional Llc. This injection, solution is formulated for epidural use and contains clonidine 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 Mylan Institutional Llc on January 26, 1997. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Clonidine is used with another medication (an opioid) to treat severe pain in people with cancer. Clonidine belongs to a class of drugs known as central alpha agonists. It works by blocking the nerves in the spinal cord that send pain signals.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457021810. 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)
67457-218-10
11-Digit CMS (5-4-2)
67457-0218-10

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