Clonidine Hydrochloride
NDC Package 40042-052-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Clonidine Hydrochloride is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Marketed by Pharmaforce, Inc., this product is identified by NDC 40042-052 and is authorized under FDA application ANDA091104.

Identification & Billing

NDC Package Code
40042-052-10
Package Description
10 mL in 1 VIAL
Product Code
40042-052
11-Digit Billing Format
40042005210
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clonidine Hydrochloride
Dosage Form
-
Usage Information
Clonidine hydrochloride is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see CLINICAL PHARMACOLOGY, Clinical Trials).The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS).

Regulatory & Marketing

Labeler Name
Pharmaforce, Inc.
FDA Application #
ANDA091104
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-16-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 40042-052-10 identifies a specific commercial package of 10 ml in 1 vial of Clonidine Hydrochloride, labeled by Pharmaforce, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Pharmaforce, Inc. on October 16, 2009. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40042005210. 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)
40042-052-10
11-Digit CMS (5-4-2)
40042-0052-10

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