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

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Baclofen (intrathecal) (baclofen) injection is baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). 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 is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles.

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.

What are the primary indications for this medication?

Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles.

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.