Baclofen (intrathecal) Injection
NDC Package 70511-124-10

11-digit billing NDC: 70511012410
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Baclofen (intrathecal) (baclofen) injection is baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. This formulation utilizes a injection delivery system. Marketed by Maia Pharmaceuticals, Inc., this product is identified by NDC 70511-124 and is authorized under FDA application ANDA210048.

Identification & Billing

NDC Package Code
70511-124-10
Package Description
1 VIAL in 1 CARTON / 20 mL in 1 VIAL
Product Code
70511-124
11-Digit Billing Format
70511012410
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Baclofen (intrathecal)
Non-Proprietary Name
Baclofen
Substance Name
Baclofen
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
Active Ingredient(s)
BACLOFEN 2000 ug/mL
Pharmacologic Class
Usage Information
Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection (intrathecal) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of baclofen injection (intrathecal) into the intrathecal space.Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of baclofen injection (intrathecal) was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three-day intrathecal infusion of baclofen injection (intrathecal) to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Baclofen injection (intrathecal) was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.Spasticity of Cerebral Origin: The efficacy of baclofen injection (intrathecal) was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; baclofen injection (intrathecal) was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross-over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p= 0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed.Baclofen injection (intrathecal) therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of baclofen injection (intrathecal), patients must show a response to baclofen injection (intrathecal) in a screening trial (see Dosage and Administration).

Regulatory & Marketing

Labeler Name
Maia Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210048
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2019
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70511-124-10 identifies a specific commercial package of 1 vial in 1 carton / 20 ml in 1 vial of Baclofen (intrathecal), a human prescription drug labeled by Maia Pharmaceuticals, Inc.. This injection is formulated for intrathecal 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 Maia Pharmaceuticals, Inc. on September 25, 2019. The current certification is valid through December 31, 2026.

How is this Maia Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70511012410. 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)
70511-124-10
11-Digit CMS (5-4-2)
70511-0124-10

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