NDC 71335-1188

ropinirole

Ropinirole

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

Product ID71335-1188_36e61918-6dae-4f7b-b110-62e2dbd9b110
NDC71335-1188
Product TypeHuman Prescription Drug
Proprietary Nameropinirole
Generic NameRopinirole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-17
Marketing CategoryANDA / ANDA
Application NumberANDA204022
Labeler NameBryant Ranch Prepack
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1188-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-1188-1)
Marketing Start Date2022-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1188-5 [71335118805]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204022
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

NDC 71335-1188-4 [71335118804]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204022
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

NDC 71335-1188-1 [71335118801]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204022
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

NDC 71335-1188-2 [71335118802]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204022
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

NDC 71335-1188-3 [71335118803]

ropinirole TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204022
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:ceb3a0cb-8677-4acd-8313-5498201e81d9
Manufacturer
UNII

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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