NDC 0597-0285 Mirapex ER

Pramipexole Dihydrochloride Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0597-0285
Proprietary Name:
Mirapex ER
Non-Proprietary Name: [1]
Pramipexole Dihydrochloride
Substance Name: [2]
Pramipexole Dihydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Labeler Code:
    0597
    FDA Application Number: [6]
    NDA022421
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-22-2010
    End Marketing Date: [10]
    07-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    9 MM
    10 MM
    Imprint(s):
    ER;0;375
    ER;0;75
    Score:
    1

    Product Packages

    NDC Code 0597-0285-30

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    Price per Unit: $23.52507 per EA

    Product Details

    What is NDC 0597-0285?

    The NDC code 0597-0285 is assigned by the FDA to the product Mirapex ER which is a human prescription drug product labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The generic name of Mirapex ER is pramipexole dihydrochloride. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 0597-0285-30 1 bottle, plastic in 1 carton / 30 tablet, extended release in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Mirapex ER?

    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.

    What are Mirapex ER Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 - A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.

    Which are Mirapex ER UNII Codes?

    The UNII codes for the active ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Mirapex ER?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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]

    Which are the Pharmacologic Classes for Mirapex ER?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Pramipexole


    Pramipexole is used alone or with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Pramipexole is also used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Pramipexole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".