Baclofen Tablet
NDC Package 55154-7635-0

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

Package Information

Baclofen tablets is baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). This formulation utilizes a tablet delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-7635 and is authorized under FDA application ANDA078220.

Identification & Billing

NDC Package Code
55154-7635-0
Package Description
10 BLISTER PACK in 1 BAG / 1 TABLET in 1 BLISTER PACK
Product Code
55154-7635
11-Digit Billing Format
55154763500
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Baclofen
Non-Proprietary Name
Baclofen
Substance Name
Baclofen
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BACLOFEN 10 mg/1
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
Cardinal Health 107, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078220
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2015
End Marketing Date
05-31-2027
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 55154-7635-0 identifies a specific commercial package of 10 blister pack in 1 bag / 1 tablet in 1 blister pack of Baclofen, a human prescription drug labeled by Cardinal Health 107, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This tablet is formulated for oral 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 Cardinal Health 107, Llc on July 15, 2015.

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 Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154763500. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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 (5-4-1)
55154-7635-0
11-Digit CMS (5-4-2)
55154-7635-00

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