NDC 68258-7163

ropinirole

Ropinirole

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

Product ID68258-7163_c5dd57e1-930a-4942-97ac-2b63f1d9a7f2
NDC68258-7163
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 NameDispensing Solutions, Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-7163-3

30 TABLET, FILM COATED in 1 BOTTLE (68258-7163-3)
Marketing Start Date2010-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-7163-3 [68258716303]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-25
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:caa8f322-325d-4117-a564-c87391ebf6fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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

    © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.