NDC 10135-677

Ropinirole

Ropinirole

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

Product ID10135-677_bb25d2e3-7586-a333-e053-2a95a90a48d1
NDC10135-677
Product TypeHuman Prescription Drug
Proprietary NameRopinirole
Generic NameRopinirole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA079165
Labeler NameMarlex Pharmaceuticals Inc
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 10135-677-01

100 TABLET, FILM COATED in 1 BOTTLE (10135-677-01)
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-677-01 [10135067701]

Ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE3 mg/1

OpenFDA Data

SPL SET ID:35d90f6f-3116-4afa-be2d-b65c160e8ab3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312845
  • 312846
  • 312847
  • 314208
  • 312849
  • 562704
  • 283858
  • UPC Code
  • 0310135674015
  • 0310135676019
  • 0310135673018
  • 0310135675012
  • 0310135678013
  • 0310135679010
  • 0310135677016
  • 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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