Pramipexole Dihydrochloride Tablet
NDC Package 33342-034-06

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

Pramipexole Dihydrochloride tablets is pramipexole is used alone or with other medications to treat Parkinson's disease. This formulation utilizes a tablet delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-034 and is authorized under FDA application ANDA202164.

Identification & Billing

NDC Package Code
33342-034-06
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
33342-034
11-Digit Billing Format
33342003406
RxNorm Crosswalk
  • 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
  • RxCUI: 859040 - pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet
  • RxCUI: 859044 - pramipexole dihydrochloride 0.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pramipexole Dihydrochloride
Non-Proprietary Name
Pramipexole Dihydrochloride
Substance Name
Pramipexole Dihydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1
Pharmacologic Class
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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202164
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33342-034). Click a package code to view its specific billing and regulatory data.

33342-034-10
90 TABLET in 1 BOTTLE
33342-034-12
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
33342-034-15
500 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 33342-034-06 identifies a specific commercial package of 30 blister pack in 1 carton / 1 tablet in 1 blister pack of Pramipexole Dihydrochloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet is formulated for oral use and contains pramipexole dihydrochloride 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 Macleods Pharmaceuticals Limited on September 21, 2012. The current certification is valid through December 31, 2026.

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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342003406. 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)
33342-034-06
11-Digit CMS (5-4-2)
33342-0034-06

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