NDC 0378-5502

Ropinirole

Ropinirole

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

Product ID0378-5502_134e48b7-a81b-41e5-8214-b6b08f9da998
NDC0378-5502
Product TypeHuman Prescription Drug
Proprietary NameRopinirole
Generic NameRopinirole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-05-05
Marketing CategoryANDA / ANDA
Application NumberANDA078881
Labeler NameMylan Pharmaceuticals Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-5502-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-5502-01)
Marketing Start Date2008-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5502-01 [00378550201]

Ropinirole Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078881
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-05-05

NDC 0378-5502-02 [00378550202]

Ropinirole Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078881
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-16
Marketing End Date2015-02-19

NDC 0378-5502-05 [00378550205]

Ropinirole Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078881
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-05
Marketing End Date2015-02-19

NDC 0378-5502-10 [00378550210]

Ropinirole Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078881
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-20
Marketing End Date2015-02-19

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:f5ce07b9-ad0d-4b72-9daf-8662775af093
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312845
  • 312846
  • 312847
  • 314208
  • 312849
  • 562704
  • 283858

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.