NDC 33342-031

Pramipexole dihydrochloride

Pramipexole Dihydrochloride

Pramipexole dihydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Pramipexole Dihydrochloride.

Product ID33342-031_17f0ff31-5e6b-4ce5-b8fb-8597c7ff634b
NDC33342-031
Product TypeHuman Prescription Drug
Proprietary NamePramipexole dihydrochloride
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-21
Marketing CategoryANDA / ANDA
Application NumberANDA202164
Labeler NameMacleods Pharmaceuticals Limited
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength0 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 33342-031-06

30 BLISTER PACK in 1 CARTON (33342-031-06) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2012-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-031-12 [33342003112]

Pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202164
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-21

NDC 33342-031-10 [33342003110]

Pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202164
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-21

NDC 33342-031-15 [33342003115]

Pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202164
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-21

NDC 33342-031-06 [33342003106]

Pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA202164
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-21

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.125 mg/1

OpenFDA Data

SPL SET ID:b8c94917-73a1-44c2-8fd8-07f45054176b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859040
  • 859048
  • 859033
  • 859044
  • 859052
    • UPC Code
  • 0333342031150

    • Pharmacological Class

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

    Medicade Reported Pricing

    33342003115 PRAMIPEXOLE 0.125 MG TABLET

    Pricing Unit: EA | Drug Type:

    33342003110 PRAMIPEXOLE 0.125 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.