Baclofen Injection
NDC Package 68055-003-20

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Baclofen injection is baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). This formulation utilizes a injection delivery system. Marketed by Sintetica S.a., this product is identified by NDC 68055-003.

Identification & Billing

NDC Package Code
68055-003-20
Package Description
840 PACKAGE in 1 CASE / 20 AMPULE in 1 PACKAGE / 20 mL in 1 AMPULE
Product Code
68055-003
11-Digit Billing Format
68055000320

Clinical Specifications

Proprietary Name
Baclofen
Non-Proprietary Name
Baclofen
Substance Name
Baclofen
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
BACLOFEN 10 mg/20mL
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
Sintetica S.a.
Product Type
Human Prescription Drug
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-19-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 68055-003-20 identifies a specific commercial package of 840 package in 1 case / 20 ampule in 1 package / 20 ml in 1 ampule of Baclofen (UNFINISHED drug), a human prescription drug labeled by Sintetica S.a.. This injection is formulated for 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 Sintetica S.a. on December 19, 2022. The current certification is valid through December 31, 2027.

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 Sintetica S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68055000320. 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)
68055-003-20
11-Digit CMS (5-4-2)
68055-0003-20

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