Mirapex
NDC Package 0597-0113-30
Package Information
Mirapex is pramipexole is used alone or with other medications to treat Parkinson's disease. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0113 and is authorized under FDA application NDA022421.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0597 - Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0113 - Mirapex
- 0597-0113-30 - 1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
- 0597-0113 - Mirapex
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 (0597-0113). Click a package code to view its specific billing and regulatory data.
* 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 0597-0113-30 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 30 tablet, extended release in 1 bottle, plastic of Mirapex ER, labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Boehringer Ingelheim Pharmaceuticals, Inc. on February 22, 2010. The current certification is valid through June 20, 2024.
What are the primary indications for this medication?
Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome"). This medication is also used to treat a certain medical condition (restless legs syndrome - RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep. Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.
How is this Boehringer Ingelheim Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597011330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.