Baclofen Suspension
NDC Package 71225-140-01

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

Package Information

Baclofen suspension is baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). This formulation utilizes a suspension delivery system. Marketed by Slayback Pharma Llc, this product is identified by NDC 71225-140 and is authorized under FDA application ANDA217252.

Identification & Billing

NDC Package Code
71225-140-01
Package Description
1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE
Product Code
71225-140
11-Digit Billing Format
71225014001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Baclofen
Non-Proprietary Name
Baclofen
Substance Name
Baclofen
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BACLOFEN 5 mg/mL
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
Slayback Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217252
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71225-140-01 identifies a specific commercial package of 1 bottle in 1 carton / 250 ml in 1 bottle of Baclofen, a human prescription drug labeled by Slayback Pharma Llc. This suspension 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 Slayback Pharma Llc on June 19, 2023. 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 Slayback Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71225014001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
71225-140-01
11-Digit CMS (5-4-2)
71225-0140-01

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