Baclofen Tablet
NDC Package 10135-533-10

11-digit billing NDC: 10135053310 · Billing unit: EA · 1000 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Baclofen tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-533 and is authorized under FDA application ANDA077241.

Identification & Billing

NDC Package Code
10135-533-10
Package Description
1000 TABLET in 1 BOTTLE, PLASTIC
Product Code
10135-533
11-Digit Billing Format
10135053310
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1000 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Baclofen
Non-Proprietary Name
Baclofen
Substance Name
Baclofen
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BACLOFEN 20 mg/1
Pharmacologic Class
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
Marlex Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA077241
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10135-533). Click a package code to view its specific billing and regulatory data.

10135-533-01
100 TABLET in 1 BOTTLE, PLASTIC
10135-533-05
500 TABLET in 1 BOTTLE, PLASTIC

* 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 10135-533-10 identifies a specific commercial package of 1000 tablet in 1 bottle, plastic of Baclofen, a human prescription drug labeled by Marlex Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1000 billable units per package. This tablet is formulated for oral use and contains baclofen 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 Marlex Pharmaceuticals Inc on May 01, 2020. The current certification is valid through December 31, 2027.

How is this Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135053310. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1000 total billable units per package. 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)
10135-533-10
11-Digit CMS (5-4-2)
10135-0533-10

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