NDC 69844-044

PRAMIPEXOLE DIHYDROCHLORIDE

Pramipexole Dihydrochloride

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

Product ID69844-044_b8230032-fa60-4c04-b5e3-6544654cb5d6
NDC69844-044
Product TypeHuman Prescription Drug
Proprietary NamePRAMIPEXOLE DIHYDROCHLORIDE
Generic NamePramipexole Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-04-06
Marketing CategoryANDA / ANDA
Application NumberANDA211088
Labeler NameGraviti Pharmaceuticals Private Limited
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69844-044-01

90 TABLET in 1 BOTTLE (69844-044-01)
Marketing Start Date2020-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69844-044-01 [69844004401]

PRAMIPEXOLE DIHYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA211088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-06

Drug Details

Active Ingredients

IngredientStrength
PRAMIPEXOLE DIHYDROCHLORIDE.75 mg/1

OpenFDA Data

SPL SET ID:85c8649f-2bde-4bb8-9f57-f609934346d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859040
  • 859048
  • 858625
  • 859044
  • 859052
  • Pharmacological Class

    • 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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