NDC 10370-306

Pramipexole Dihydrochloride Extended-Release

Pramipexole

Pramipexole Dihydrochloride Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Pramipexole Dihydrochloride.

Product ID10370-306_2b6f1e16-0d57-41c5-adf8-45a3fdb21670
NDC10370-306
Product TypeHuman Prescription Drug
Proprietary NamePramipexole Dihydrochloride Extended-Release
Generic NamePramipexole
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-07-05
Marketing CategoryANDA / ANDA
Application NumberANDA202206
Labeler NamePar Pharmaceutical, Inc.
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10370-306-11

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-306-11)
Marketing Start Date2016-07-05
Marketing End Date2023-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10370-306-11 [10370030611]

Pramipexole Dihydrochloride Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202206
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-05

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE3.75 mg/1

OpenFDA Data

SPL SET ID:79d73ae4-beaf-4a99-b0f3-d66438c122bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 901534
  • 901550
  • 901555
  • 901546
  • 1114485
  • 901541
  • 1114479

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Pramipexole Dihydrochloride Extended-Release" or generic name "Pramipexole"

    NDCBrand NameGeneric Name
    31722-906PRAMIPEXOLEPRAMIPEXOLE
    31722-907PRAMIPEXOLEPRAMIPEXOLE
    31722-908PRAMIPEXOLEPRAMIPEXOLE
    31722-909PRAMIPEXOLEPRAMIPEXOLE
    31722-910PRAMIPEXOLEPRAMIPEXOLE
    31722-911PRAMIPEXOLEPRAMIPEXOLE
    50090-3009PRAMIPEXOLEPRAMIPEXOLE
    10370-251Pramipexole DihydrochloridePramipexole
    10370-252Pramipexole DihydrochloridePramipexole
    10370-253Pramipexole DihydrochloridePramipexole
    10370-254Pramipexole DihydrochloridePramipexole
    10370-255Pramipexole DihydrochloridePramipexole
    10370-305Pramipexole DihydrochloridePramipexole
    10370-306Pramipexole DihydrochloridePramipexole
    42291-557Pramipexole DihydrochloridePramipexole
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