Pramipexole Dihydrochloride
NDC Package 42543-708-05

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Pramipexole Dihydrochloride is pramipexole is used alone or with other medications to treat Parkinson's disease. Marketed by Vensun Pharmaceuticals, Inc., this product is identified by NDC 42543-708 and is authorized under FDA application ANDA203855.

Identification & Billing

NDC Package Code
42543-708-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
42543-708
11-Digit Billing Format
42543070805
RxNorm Crosswalk
  • RxCUI: 858625 - pramipexole dihydrochloride 0.75 MG Oral Tablet
  • RxCUI: 858625 - pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet
  • RxCUI: 859033 - pramipexole dihydrochloride 0.125 MG Oral Tablet
  • RxCUI: 859033 - pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet
  • RxCUI: 859040 - pramipexole dihydrochloride 0.25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pramipexole Dihydrochloride
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Vensun Pharmaceuticals, Inc.
FDA Application #
ANDA203855
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-29-2014
Listing Expiration
12-31-2019
Exclude Flag
I
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 (42543-708). Click a package code to view its specific billing and regulatory data.

42543-708-10
1000 TABLET in 1 BOTTLE
42543-708-90
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 42543-708-05 identifies a specific commercial package of 500 tablet in 1 bottle of Pramipexole Dihydrochloride, labeled by Vensun 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 Vensun Pharmaceuticals, Inc. on October 29, 2014. The current certification is valid through December 31, 2019.

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 Vensun Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42543070805. 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)
42543-708-05
11-Digit CMS (5-4-2)
42543-0708-05

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