NDC 0228-3659

Ropinirole

Ropinirole

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

Product ID0228-3659_1b7e2a57-a819-48ae-8a01-89b5095fc1b6
NDC0228-3659
Product TypeHuman Prescription Drug
Proprietary NameRopinirole
Generic NameRopinirole
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-08-23
Marketing CategoryANDA / ANDA
Application NumberANDA090869
Labeler NameActavis Pharma, Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0228-3659-03

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3659-03)
Marketing Start Date2012-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0228-3659-03 [00228365903]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090869
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-23

NDC 0228-3659-09 [00228365909]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090869
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-23

NDC 0228-3659-50 [00228365950]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090869
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-23
Marketing End Date2012-08-23

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:300946bf-2f83-471d-868d-9820b65c52bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 799056
  • 799054
  • 799055
  • 848582
  • 824959
    • UPC Code
  • 0302283659037
  • 0302283661030
  • 0302283658030
  • 0302283640035
  • 0302283660033

    • Pharmacological Class

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