Baclofen Tablet
NDC Package 72189-565-82

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Direct_rx, this product is identified by NDC 72189-565 and is authorized under FDA application ANDA214374.

Identification & Billing

NDC Package Code
72189-565-82
Package Description
180 TABLET in 1 BOTTLE
Product Code
72189-565
11-Digit Billing Format
72189056582
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
RxNorm Crosswalk
RxCUI: 197392 - baclofen 20 MG Oral Tablet

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 20 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
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA214374
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-28-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72189-565). Click a package code to view its specific billing and regulatory data.

72189-565-60
60 TABLET in 1 BOTTLE
72189-565-90
90 TABLET in 1 BOTTLE

* 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 72189-565-82 identifies a specific commercial package of 180 tablet in 1 bottle of Baclofen, a human prescription drug labeled by Direct_rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 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 Direct_rx on June 28, 2024. 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 Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189056582. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 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)
72189-565-82
11-Digit CMS (5-4-2)
72189-0565-82

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