NDC 71335-0447

ropinirole

Ropinirole

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

Product ID71335-0447_cbc3905f-e2bc-4eaa-8166-2774d6d11390
NDC71335-0447
Product TypeHuman Prescription Drug
Proprietary Nameropinirole
Generic NameRopinirole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-02-25
Marketing CategoryANDA / ANDA
Application NumberANDA090135
Labeler NameBryant Ranch Prepack
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0447-3

90 TABLET, FILM COATED in 1 BOTTLE (71335-0447-3)
Marketing Start Date2016-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0447-1 [71335044701]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-15
Marketing End Date2019-05-31

NDC 71335-0447-4 [71335044704]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-15
Marketing End Date2019-05-31

NDC 71335-0447-3 [71335044703]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-15
Marketing End Date2019-05-31

NDC 71335-0447-2 [71335044702]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-15
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:cc80be71-8856-42f6-ab76-6090049342a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314208
  • 312845
  • 312846
  • 312847
  • 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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