NDC 63629-6452

Ropinirole

Ropinirole

Ropinirole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ropinirole Hydrochloride.

Product ID63629-6452_5d40a578-72d3-4024-8f6b-2aa61a8405ec
NDC63629-6452
Product TypeHuman Prescription Drug
Proprietary NameRopinirole
Generic NameRopinirole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-05-05
Marketing CategoryANDA / ANDA
Application NumberANDA077852
Labeler NameBryant Ranch Prepack
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-6452-1

60 TABLET in 1 BOTTLE (63629-6452-1)
Marketing Start Date2017-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-6452-2 [63629645202]

Ropinirole TABLET
Marketing CategoryANDA
Application NumberANDA077852
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-22
Inactivation Date2020-01-31

NDC 63629-6452-1 [63629645201]

Ropinirole TABLET
Marketing CategoryANDA
Application NumberANDA077852
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-22
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE3 mg/1

OpenFDA Data

SPL SET ID:fc1f418c-f229-4bf0-88a6-1b2c84a18041
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283858
  • 312847
  • 562704
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Ropinirole" or generic name "Ropinirole"

    NDCBrand NameGeneric Name
    0054-0116RopinirolerOPINIRole
    0054-0117RopinirolerOPINIRole
    0054-0118RopinirolerOPINIRole
    0054-0119RopinirolerOPINIRole
    0054-0120RopinirolerOPINIRole
    0054-0121RopinirolerOPINIRole
    0054-0122RopinirolerOPINIRole
    0228-3640RopiniroleRopinirole
    0228-3658RopiniroleRopinirole
    0228-3659RopiniroleRopinirole
    0228-3660RopiniroleRopinirole
    0228-3661RopiniroleRopinirole
    0378-5501Ropiniroleropinirole
    0378-5502Ropiniroleropinirole
    68151-4073RopiniroleRopinirole
    68151-4071RopiniroleRopinirole
    68151-4072RopiniroleRopinirole
    68258-7163ropiniroleropinirole
    68462-259ropiniroleropinirole
    68462-253ropiniroleropinirole
    68462-255ropiniroleropinirole
    68462-256ropiniroleropinirole
    68462-258ropiniroleropinirole
    68462-254ropiniroleropinirole
    68462-257ropiniroleropinirole
    71335-0064ropiniroleropinirole
    71335-0560ropiniroleropinirole
    71335-0447ropiniroleropinirole
    71335-0631ropiniroleropinirole
    0781-5786ropiniroleropinirole
    0781-5782ropiniroleropinirole
    0781-5784ropiniroleropinirole
    0781-5780ropiniroleropinirole
    0781-5788ropiniroleropinirole
    10135-673RopiniroleRopinirole
    10135-674RopiniroleRopinirole
    10135-675RopiniroleRopinirole
    10135-679RopiniroleRopinirole
    10135-678RopiniroleRopinirole
    10135-677RopiniroleRopinirole
    10135-676RopiniroleRopinirole
    13811-639RopiniroleRopinirole
    13811-643RopiniroleRopinirole
    13811-641RopiniroleRopinirole
    13811-640RopiniroleRopinirole
    13811-642RopiniroleRopinirole
    16729-235ropiniroleropinirole
    16729-234ropiniroleropinirole
    16729-233ropiniroleropinirole
    16729-237ropiniroleropinirole

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