NDC 13668-095

Pramipexole Dihydrochloride

Pramipexole Dihydrochloride

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

Product ID13668-095_464ce687-ddcf-4725-b0a2-b181241955b7
NDC13668-095
Product TypeHuman Prescription Drug
Proprietary NamePramipexole Dihydrochloride
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA090865
Labeler NameTorrent Pharmaceuticals Limited
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13668-095-05

500 TABLET in 1 BOTTLE (13668-095-05)
Marketing Start Date2010-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-095-90 [13668009590]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090865
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-08

NDC 13668-095-30 [13668009530]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090865
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08

NDC 13668-095-05 [13668009505]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090865
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-08

NDC 13668-095-15 [13668009515]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090865
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08

NDC 13668-095-74 [13668009574]

Pramipexole Dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090865
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-08

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE1.5 mg/1

OpenFDA Data

SPL SET ID:60167d7c-469f-455a-a113-561841af5e59
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859033
  • 859052
  • 859048
  • 859040
  • 858625
  • 859044
    • UPC Code
  • 0313668092059
  • 0313668184051
  • 0313668095050
  • 0313668094053
  • 0313668093056

    • Pharmacological Class

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

    Medicade Reported Pricing

    13668009590 PRAMIPEXOLE 1.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    13668009505 PRAMIPEXOLE 1.5 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.