Clonidine
NDC Package 65038-040-03

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 discontinued by the firm.

Clonidine is a medication used alone or with other medications to treat high blood pressure (hypertension). Marketed by Corium International, Inc., this product is identified by NDC 65038-040 and is authorized under FDA application ANDA079090.

Identification & Billing

NDC Package Code
65038-040-03
Package Description
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 24 h in 1 PATCH
Product Code
65038-040
11-Digit Billing Format
65038004003

Clinical Specifications

Proprietary Name
Clonidine
Dosage Form
-
Usage Information
This medication is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Clonidine belongs to a class of drugs (central alpha agonists) that act in the brain to lower blood pressure. It works by relaxing blood vessels so blood can flow more easily.

Regulatory & Marketing

Labeler Name
Corium International, Inc.
FDA Application #
ANDA079090
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-03-2016
End Marketing Date
08-12-2016
Listing Expiration
08-12-2016
Exclude Flag
D
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 65038-040-03 identifies a specific commercial package of 4 pouch in 1 carton / 1 patch in 1 pouch / 24 h in 1 patch of Clonidine, labeled by Corium International, 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 Corium International, Inc. on August 03, 2016. The current certification is valid through August 12, 2016.

What are the primary indications for this medication?

This medication is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Clonidine belongs to a class of drugs (central alpha agonists) that act in the brain to lower blood pressure. It works by relaxing blood vessels so blood can flow more easily.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65038004003. 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)
65038-040-03
11-Digit CMS (5-4-2)
65038-0040-03

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