Ozobax Solution
NDC Package 69528-302-08

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

Ozobax (baclofen) solution is baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). This formulation utilizes a solution delivery system. Marketed by Rosemont Pharmaceuticals Llc, this product is identified by NDC 69528-302 and is authorized under FDA application NDA208193.

Identification & Billing

NDC Package Code
69528-302-08
Package Description
237 mL in 1 BOTTLE
Product Code
69528-302
11-Digit Billing Format
69528030208
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ozobax DS
Non-Proprietary Name
Baclofen
Substance Name
Baclofen
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BACLOFEN 10 mg/5mL
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
Rosemont Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208193
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-12-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69528-302). Click a package code to view its specific billing and regulatory data.

69528-302-16
473 mL 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 69528-302-08 identifies a specific commercial package of 237 ml in 1 bottle of Ozobax DS, a human prescription drug labeled by Rosemont Pharmaceuticals Llc. This solution 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 Rosemont Pharmaceuticals Llc on October 12, 2023. 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 Rosemont Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69528030208. 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)
69528-302-08
11-Digit CMS (5-4-2)
69528-0302-08

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