NDC 0597-0285

Mirapex ER

Pramipexole Dihydrochloride

Mirapex ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Pramipexole Dihydrochloride.

Product ID0597-0285_52132628-35e3-4594-a642-da7162158112
NDC0597-0285
Product TypeHuman Prescription Drug
Proprietary NameMirapex ER
Generic NamePramipexole Dihydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-02-22
Marketing CategoryNDA / NDA
Application NumberNDA022421
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0597-0285-30

1 BOTTLE, PLASTIC in 1 CARTON (0597-0285-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Start Date2010-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0285-17 [00597028517]

Mirapex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022421
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-22

NDC 0597-0285-30 [00597028530]

Mirapex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022421
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-22

NDC 0597-0285-07 [00597028507]

Mirapex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-22
Marketing End Date2013-02-11

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.75 mg/1

OpenFDA Data

SPL SET ID:e2902ed1-cfeb-4815-adc3-129c577917a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 901534
  • 1114481
  • 901550
  • 901551
  • 901555
  • 901557
  • 901547
  • 901546
  • 901543
  • 901537
  • 901541
  • 1114487
  • 1114479
  • 1114485

    • Pharmacological Class

    • Dopamine Agonists [MoA]
    • Nonergot Dopamine Agonist [EPC]

    NDC Crossover Matching brand name "Mirapex ER" or generic name "Pramipexole Dihydrochloride"

    NDCBrand NameGeneric Name
    0597-0287Mirapex ERMirapex ER
    0597-0286Mirapex ERMirapex ER
    0597-0101Mirapexpramipexole dihydrochloride
    0597-0109Mirapexpramipexole dihydrochloride
    0597-0113Mirapexpramipexole dihydrochloride
    0597-0115Mirapexpramipexole dihydrochloride
    0597-0116Mirapexpramipexole dihydrochloride
    0597-0183Mirapexpramipexole dihydrochloride
    0597-0184Mirapexpramipexole dihydrochloride
    0597-0185Mirapexpramipexole dihydrochloride
    0597-0190Mirapexpramipexole dihydrochloride
    0597-0191Mirapexpramipexole dihydrochloride
    0597-0285Mirapexpramipexole dihydrochloride

    Trademark Results [Mirapex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MIRAPEX
    MIRAPEX
    75027783 2062274 Live/Registered
    BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
    1995-12-04
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