NDC 68462-627

Pramipexole dihydrochloride

Pramipexole Dihydrochloride

Pramipexole dihydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Pramipexole Dihydrochloride.

Product ID68462-627_0c8662c6-e1d5-4d5a-b180-cf33c69c7b44
NDC68462-627
Product TypeHuman Prescription Drug
Proprietary NamePramipexole dihydrochloride
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA090781
Labeler NameGlenmark Pharmaceuticals Inc., USA
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 68462-627-05

500 TABLET in 1 BOTTLE (68462-627-05)
Marketing Start Date2016-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-627-05 [68462062705]

Pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-31

NDC 68462-627-90 [68462062790]

Pramipexole dihydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-31

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.75 mg/1

OpenFDA Data

SPL SET ID:44c336d2-01d1-4f13-bad9-549cdc3505ec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859033
  • 859052
  • 859048
  • 859040
  • 858625
  • 859044
  • UPC Code
  • 0368462331903
  • 0368462330906
  • 0368462333907
  • 0368462334904
  • 0368462332900
  • Pharmacological Class

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

    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

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