NDC 68084-974

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Pramipexole Dihydrochloride.

Product ID68084-974_7c39217f-ff2d-7201-e053-2a91aa0a783a
NDC68084-974
Product TypeHuman Prescription Drug
Proprietary NamePramipexole Dihydrochloride
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA078920
Labeler NameAmerican Health Packaging
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68084-974-25

30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-974-25) > 1 TABLET in 1 BLISTER PACK (68084-974-95)
Marketing Start Date2015-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68084-974-95 [68084097495]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078920
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-01
Marketing End Date2020-06-30

NDC 68084-974-25 [68084097425]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078920
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-01
Marketing End Date2020-06-30

NDC 68084-974-21 [68084097421]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078920
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-31
Marketing End Date2015-12-31

NDC 68084-974-11 [68084097411]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078920
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-31
Marketing End Date2020-06-30

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:5b15a21d-cde6-4c9f-b9b2-b747ded70931
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859040
  • 859033
  • 859044
  • 859052

    • Pharmacological Class

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

    Medicade Reported Pricing

    68084097495 PRAMIPEXOLE 0.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084097425 PRAMIPEXOLE 0.5 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    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
    0615-7597Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5249Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5248Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5252Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5281Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5250Pramipexole DihydrochloridePramipexole Dihydrochloride
    0781-5251Pramipexole 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
    16714-922Pramipexole DihydrochloridePramipexole Dihydrochloride
    16714-918Pramipexole DihydrochloridePramipexole Dihydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.