NDC Package 58281-561-02 Lioresal

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

58281-561-02

Package Description:

2 AMPULE in 1 PACKAGE, COMBINATION / 5 mL in 1 AMPULE

Product Code:

58281-561

Proprietary Name:

Lioresal

Usage Information:

LIORESAL INTRATHECAL (baclofen injection) 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 LIORESAL 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. LIORESAL 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 LIORESAL INTRATHECAL into the intrathecal space. Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of LIORESAL INTRATHECAL was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of LIORESAL INTRATHECAL to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. LIORESAL 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 LIORESAL 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; LIORESAL 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. LIORESAL INTRATHECAL therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of LIORESAL INTRATHECAL, patients must show a response to LIORESAL INTRATHECAL in a screening trial (see Dosage and Administration).

11-Digit NDC Billing Format:

58281056102

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 1666613 - baclofen 40 MG in 20 ML (2,000 MCG/ML) Injection

RxCUI: 1666613 - 20 ML baclofen 2 MG/ML Injection

RxCUI: 1666613 - baclofen 40,000 MCG per 20 ML Injection

RxCUI: 1666620 - LIORESAL INTRATHECAL 40 MG in 20 ML (2,000 MCG/ML) Injection

RxCUI: 1666620 - 20 ML baclofen 2 MG/ML Injection [Lioresal]

Labeler Name:

Medtronic Neuromodulation

Sample Package:

Start Marketing Date:

06-17-1992

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

58281 - Medtronic Neuromodulation
- 58281-561 - Lioresal
  - 58281-561-02 - 2 AMPULE in 1 PACKAGE, COMBINATION / 5 mL in 1 AMPULE

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 disclaimer below.

Frequently Asked Questions

What is NDC 58281-561-02?

The NDC Packaged Code 58281-561-02 is assigned to a package of 2 ampule in 1 package, combination / 5 ml in 1 ampule of Lioresal, labeled by Medtronic Neuromodulation. The product's dosage form is and is administered via form.

Is NDC 58281-561 included in the NDC Directory?

No, Lioresal with product code 58281-561 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Medtronic Neuromodulation on June 17, 1992 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 58281-561-02?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 58281-561-02?

The 11-digit format is 58281056102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	58281-561-02	5-4-2	58281-0561-02

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