NDC 21695-867

Mirapex

Pramipexole Dihydrochloride

Mirapex is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Pramipexole Dihydrochloride.

Product ID21695-867_b5504316-3907-444c-b604-ec9a18cdcd6d
NDC21695-867
Product TypeHuman Prescription Drug
Proprietary NameMirapex
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-01-01
Marketing CategoryNDA / NDA
Application NumberNDA020667
Labeler NameRebel Distributors Corp
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-867-90

90 TABLET in 1 BOTTLE (21695-867-90)
Marketing Start Date2004-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-867-90 [21695086790]

Mirapex TABLET
Marketing CategoryNDA
Application NumberNDA020667
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-01-01
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:b5504316-3907-444c-b604-ec9a18cdcd6d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859044
  • 859046

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    21695-867MirapexMirapex

    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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