Baclofen (intrathecal)
NDC Package 71525-005-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Baclofen (intrathecal) is baclofen Injection (Intrathecal) is indicated for use in the management of severe spasticity. Marketed by Emerald International Limited, this product is identified by NDC 71525-005 and is authorized under FDA application ANDA091193.

Identification & Billing

NDC Package Code
71525-005-10
Package Description
10 AMPULE in 1 BOX / 1 mL in 1 AMPULE (71525-005-01)
Product Code
71525-005
11-Digit Billing Format
71525000510
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Baclofen (intrathecal)
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Emerald International Limited
FDA Application #
ANDA091193
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2018
Listing Expiration
12-31-2022
Exclude Flag
I
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 71525-005-10 identifies a specific commercial package of 10 ampule in 1 box / 1 ml in 1 ampule (71525-005-01) of Baclofen (intrathecal), labeled by Emerald International 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 Emerald International Limited on December 01, 2018. The current certification is valid through December 31, 2022.

How is this Emerald International Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71525000510. 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)
71525-005-10
11-Digit CMS (5-4-2)
71525-0005-10

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