Baclofen
NDC Package 45865-355-51

11-digit billing NDC: 45865035551
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.

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-355 and is authorized under FDA application ANDA077241.

Identification & Billing

NDC Package Code
45865-355-51
Package Description
120 TABLET in 1 BOTTLE, PLASTIC
Product Code
45865-355
11-Digit Billing Format
45865035551
RxNorm Crosswalk
RxCUI: 197392 - baclofen 20 MG Oral Tablet

Clinical Specifications

Proprietary Name
Baclofen
Dosage Form
-
Usage Information
Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
FDA Application #
ANDA077241
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2005
Listing Expiration
12-31-2024
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 45865-355-51 identifies a specific commercial package of 120 tablet in 1 bottle, plastic of Baclofen, labeled by Medsource Pharmaceuticals. 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 Medsource Pharmaceuticals on December 01, 2005. The current certification is valid through December 31, 2024.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865035551. 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)
45865-355-51
11-Digit CMS (5-4-2)
45865-0355-51

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