Baclofen Solution
NDC Package 42192-631-40

11-digit billing NDC: 42192063140
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Baclofen solution is baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Limitations of Use Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. This formulation utilizes a solution delivery system. Marketed by Acella Pharmaceuticals, Llc, this product is identified by NDC 42192-631 and is authorized under FDA application NDA208193.

Identification & Billing

NDC Package Code
42192-631-40
Package Description
40 CUP, UNIT-DOSE in 1 CASE / 10 mL in 1 CUP, UNIT-DOSE (42192-631-10)
Product Code
42192-631
11-Digit Billing Format
42192063140

Clinical Specifications

Proprietary Name
Baclofen
Non-Proprietary Name
Baclofen
Substance Name
Baclofen
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BACLOFEN 10 mg/5mL
Pharmacologic Class
Usage Information
Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Limitations of Use Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Regulatory & Marketing

Labeler Name
Acella Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208193
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-26-2026
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 (42192-631). Click a package code to view its specific billing and regulatory data.

42192-631-45
40 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE (42192-631-05)

* 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 42192-631-40 identifies a specific commercial package of 40 cup, unit-dose in 1 case / 10 ml in 1 cup, unit-dose (42192-631-10) of Baclofen, a human prescription drug labeled by Acella Pharmaceuticals, Llc. This solution 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 Acella Pharmaceuticals, Llc on October 26, 2026. The current certification is valid through December 31, 2027.

How is this Acella Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42192063140. 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)
42192-631-40
11-Digit CMS (5-4-2)
42192-0631-40

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