NDC 46708-263

Ropinirole

Ropinirole

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

Product ID46708-263_2e01dbdd-f439-45d7-9085-2d92a1a1fee2
NDC46708-263
Product TypeHuman Prescription Drug
Proprietary NameRopinirole
Generic NameRopinirole
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA202786
Labeler NameAlembic Pharmaceuticals Limited
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46708-263-10

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-263-10)
Marketing Start Date2013-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-263-91 [46708026391]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-14

NDC 46708-263-10 [46708026310]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-14

NDC 46708-263-71 [46708026371]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-14

NDC 46708-263-90 [46708026390]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-14

NDC 46708-263-31 [46708026331]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-14

NDC 46708-263-30 [46708026330]

Ropinirole TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-14

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:2e01dbdd-f439-45d7-9085-2d92a1a1fee2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 799056
  • 799054
  • 799055
  • 848582
  • 824959
    • UPC Code
  • 0346708265304
  • 0346708266301
  • 0346708263300
  • 0346708264307
  • 0346708262303

    • 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
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