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  5. NDC Package Code: 0597-0116-30 Mirapex ER

NDC Package 0597-0116-30 Mirapex ER

Pramipexole Dihydrochloride Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0597-0116-30
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
0597-0116
Proprietary Name:
Mirapex ER
Non-Proprietary Name:
Pramipexole Dihydrochloride
Substance Name:
Pramipexole Dihydrochloride
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.
11-Digit NDC Billing Format:
00597011630
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1114479 - pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1114479 - 24 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral Tablet
  • RxCUI: 1114479 - pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1114481 - Mirapex ER 2.25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1114481 - 24 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral Tablet [Mirapex]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1
    • Pharmacologic Class(es):
  • Dopamine Agonists - [MoA] (Mechanism of Action)
  • Nonergot Dopamine Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA022421
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-22-2010
    End Marketing Date:
    06-30-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0116-30?

    The NDC Packaged Code 0597-0116-30 is assigned to a package of 1 bottle, plastic in 1 carton / 30 tablet, extended release in 1 bottle, plastic of Mirapex ER, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 0597-0116 included in the NDC Directory?

    Yes, Mirapex ER with product code 0597-0116 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on February 22, 2010.

    What is the NDC billing unit for package 0597-0116-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0597-0116-30?

    The 11-digit format is 00597011630. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20597-0116-305-4-200597-0116-30