NDC 63629-4971

Ropinirole Hydrochloride

Ropinirole Hydrochloride

Ropinirole Hydrochloride 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 ID63629-4971_816eabba-6b66-4eb3-911d-e1f0b0d679e4
NDC63629-4971
Product TypeHuman Prescription Drug
Proprietary NameRopinirole Hydrochloride
Generic NameRopinirole Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-09-18
Marketing CategoryANDA / ANDA
Application NumberANDA090429
Labeler NameBryant Ranch Prepack
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 63629-4971-1

30 TABLET, FILM COATED in 1 BOTTLE (63629-4971-1)
Marketing Start Date2009-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4971-1 [63629497101]

Ropinirole Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090429
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-18
Inactivation Date2019-11-27

NDC 63629-4971-2 [63629497102]

Ropinirole Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090429
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-18
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:3d4ea23a-c4d9-4983-94e7-b76ed752a641
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312847
  • Pharmacological Class

    • Dopamine Agonists [MoA]
    • Nonergot Dopamine Agonist [EPC]

    NDC Crossover Matching brand name "Ropinirole Hydrochloride" or generic name "Ropinirole Hydrochloride"

    NDCBrand NameGeneric Name
    0378-5501Ropinirole Hydrochlorideropinirole
    0378-5502Ropinirole Hydrochlorideropinirole
    0378-5503Ropinirole Hydrochlorideropinirole
    0378-5504Ropinirole Hydrochlorideropinirole
    0378-5505Ropinirole Hydrochlorideropinirole
    0378-5525Ropinirole Hydrochlorideropinirole
    0378-5550Ropinirole Hydrochlorideropinirole
    0615-7536Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7537Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7538Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7539Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7567Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-8188ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8189ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8190ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8191ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0904-6373ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0904-6374ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-792ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-793ropinirole hydrochlorideropinirole hydrochloride
    21695-794ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-798ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    43353-194ropinirole hydrochlorideropinirole hydrochloride
    43353-195ropinirole hydrochlorideropinirole hydrochloride
    68258-7162Ropinirole HydrochlorideRopinirole Hydrochloride
    68382-340ropinirole hydrochlorideropinirole hydrochloride
    68382-342ropinirole hydrochlorideropinirole hydrochloride
    68382-338ropinirole hydrochlorideropinirole hydrochloride
    68382-343ropinirole hydrochlorideropinirole hydrochloride
    68382-344ropinirole hydrochlorideropinirole hydrochloride
    68382-339ropinirole hydrochlorideropinirole hydrochloride
    68382-341ropinirole hydrochlorideropinirole hydrochloride
    71335-0728ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    71335-0829ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    71335-0727ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    43353-265Ropinirole HydrochlorideRopinirole Hydrochloride
    43547-273ropinirole hydrochlorideropinirole hydrochloride
    43353-267Ropinirole HydrochlorideRopinirole Hydrochloride
    43353-196ropinirole hydrochlorideropinirole hydrochloride
    43353-198ropinirole hydrochlorideropinirole hydrochloride
    43353-258Ropinirole HydrochlorideRopinirole Hydrochloride
    43353-266Ropinirole HydrochlorideRopinirole Hydrochloride
    43547-270ropinirole hydrochlorideropinirole hydrochloride
    43547-271ropinirole hydrochlorideropinirole hydrochloride
    43547-268ropinirole hydrochlorideropinirole hydrochloride
    43547-269ropinirole hydrochlorideropinirole hydrochloride
    43547-274ropinirole hydrochlorideropinirole hydrochloride
    43547-272ropinirole hydrochlorideropinirole hydrochloride
    46708-032ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    46708-030ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE

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