Gablofen
NDC Package 45945-151-01

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 discontinued by the firm.

Gablofen is baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). Marketed by Mallinckrodt Inc (brand Pharmaceuticals), this product is identified by NDC 45945-151 and is authorized under FDA application NDA022462.

Identification & Billing

NDC Package Code
45945-151-01
Package Description
1 mL in 1 SYRINGE, GLASS
Product Code
45945-151
11-Digit Billing Format
45945015101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML

Clinical Specifications

Proprietary Name
Gablofen
Dosage Form
-
Usage Information
Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). It works by helping to relax the muscles. Baclofen injection is used by patients who do not respond to or who cannot tolerate the side effects of baclofen taken by mouth.

Regulatory & Marketing

Labeler Name
Mallinckrodt Inc (brand Pharmaceuticals)
FDA Application #
NDA022462
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-19-2010
End Marketing Date
01-31-2018
Listing Expiration
01-31-2018
Exclude Flag
D
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 45945-151-01 identifies a specific commercial package of 1 ml in 1 syringe, glass of Gablofen, labeled by Mallinckrodt Inc (brand Pharmaceuticals). This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. 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 Mallinckrodt Inc (brand Pharmaceuticals) on November 19, 2010. The current certification is valid through January 31, 2018.

What are the primary indications for this medication?

Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). It works by helping to relax the muscles. Baclofen injection is used by patients who do not respond to or who cannot tolerate the side effects of baclofen taken by mouth.

How is this Mallinckrodt Inc (brand Pharmaceuticals) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45945015101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 total billable units per package. 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)
45945-151-01
11-Digit CMS (5-4-2)
45945-0151-01

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