Baclofen
NDC Package 42571-428-05

11-digit billing NDC: 42571042805
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Baclofen is tablets are 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. Marketed by Micro Labs Limited, this product is identified by NDC 42571-428 and is authorized under FDA application ANDA217687.

Identification & Billing

NDC Package Code
42571-428-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
42571-428
11-Digit Billing Format
42571042805

Clinical Specifications

Proprietary Name
Baclofen
Dosage Form
-
Usage Information
Baclofen tablets are 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 tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Baclofen tablets are 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
Micro Labs Limited
FDA Application #
ANDA217687
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2024
End Marketing Date
08-05-2026
Listing Expiration
08-05-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42571-428). Click a package code to view its specific billing and regulatory data.

42571-428-01
100 TABLET in 1 BOTTLE
42571-428-13
1000 TABLET in 1 BOTTLE

* 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 42571-428-05 identifies a specific commercial package of 500 tablet in 1 bottle of Baclofen, labeled by Micro Labs Limited. 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 Micro Labs Limited on April 01, 2024. The current certification is valid through August 05, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571042805. 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)
42571-428-05
11-Digit CMS (5-4-2)
42571-0428-05

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