NDC 64380-748

pramipexole dihydrochloride

Pramipexole Dihydrochloride

pramipexole dihydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Pramipexole Dihydrochloride.

Product ID64380-748_0b1d1374-e9e6-4cf6-825d-491d06092dce
NDC64380-748
Product TypeHuman Prescription Drug
Proprietary Namepramipexole dihydrochloride
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-06-03
Marketing CategoryANDA / ANDA
Application NumberANDA202702
Labeler NameStrides Pharma Science Limited
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64380-748-01

10 BLISTER PACK in 1 CARTON (64380-748-01) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2021-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64380-748-01 [64380074801]

pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202702
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-03

NDC 64380-748-05 [64380074805]

pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202702
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-03

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:fb2260d6-204c-4d25-a331-0f8340d83a6e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859033
  • 859052
  • 859048
  • 859040
  • 858625
  • 859044
  • Pharmacological Class

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

    NDC Crossover Matching brand name "pramipexole dihydrochloride" or generic name "Pramipexole Dihydrochloride"

    NDCBrand NameGeneric Name
    0615-7597Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5248Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5249Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5250Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5251Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5252Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5281Pramipexole DihydrochloridePramipexole Dihydrochloride
    0904-6704Pramipexole DihydrochloridePramipexole Dihydrochloride
    10370-251Pramipexole DihydrochloridePramipexole
    68084-793Pramipexole DihydrochloridePramipexole Dihydrochloride
    68084-982Pramipexole DihydrochloridePramipexole Dihydrochloride
    68084-440Pramipexole DihydrochloridePramipexole Dihydrochloride
    68084-974Pramipexole DihydrochloridePramipexole Dihydrochloride
    68151-3966Pramipexole DihydrochloridePramipexole Dihydrochloride
    68151-0329Pramipexole DihydrochloridePramipexole Dihydrochloride
    68151-3645Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-196Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-198Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-199Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-475Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-200Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-476Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-875Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-477Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-197Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-474Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-478Pramipexole DihydrochloridePramipexole Dihydrochloride
    68382-874Pramipexole DihydrochloridePramipexole Dihydrochloride
    68462-627Pramipexole dihydrochloridePramipexole dihydrochloride
    68462-330Pramipexole dihydrochloridePramipexole dihydrochloride
    68462-332Pramipexole dihydrochloridePramipexole dihydrochloride
    68462-334Pramipexole dihydrochloridePramipexole dihydrochloride
    68462-333Pramipexole dihydrochloridePramipexole dihydrochloride
    68462-331Pramipexole dihydrochloridePramipexole dihydrochloride
    70771-1330Pramipexole DihydrochloridePramipexole Dihydrochloride
    70771-1333Pramipexole DihydrochloridePramipexole Dihydrochloride
    70771-1329Pramipexole DihydrochloridePramipexole Dihydrochloride
    70771-1334Pramipexole DihydrochloridePramipexole Dihydrochloride
    70771-1328Pramipexole DihydrochloridePramipexole Dihydrochloride
    70771-1331Pramipexole DihydrochloridePramipexole Dihydrochloride
    70771-1332Pramipexole DihydrochloridePramipexole Dihydrochloride
    71335-0584Pramipexole DihydrochloridePramipexole Dihydrochloride
    13668-095Pramipexole DihydrochloridePramipexole Dihydrochloride
    13668-184Pramipexole DihydrochloridePramipexole Dihydrochloride
    13668-092Pramipexole DihydrochloridePramipexole Dihydrochloride
    13668-091Pramipexole DihydrochloridePramipexole Dihydrochloride
    13668-094Pramipexole DihydrochloridePramipexole Dihydrochloride
    13668-093Pramipexole DihydrochloridePramipexole Dihydrochloride
    16714-920Pramipexole DihydrochloridePramipexole Dihydrochloride
    16714-916Pramipexole DihydrochloridePramipexole Dihydrochloride

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