NDC 0781-5786

ropinirole

Ropinirole

ropinirole is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Ropinirole Hydrochloride.

Product ID0781-5786_62610145-8e1d-402e-92b2-14c6f16ce860
NDC0781-5786
Product TypeHuman Prescription Drug
Proprietary Nameropinirole
Generic NameRopinirole
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA201047
Labeler NameSandoz Inc
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0781-5786-31

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5786-31)
Marketing Start Date2012-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5786-31 [00781578631]

ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-01

NDC 0781-5786-92 [00781578692]

ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA201047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-01

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:2ed1aae8-ca68-41f7-8922-3662329117c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 799056
  • 799054
  • 799055
  • 848582
  • 824959
  • 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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