NDC 43547-268

ropinirole hydrochloride

Ropinirole Hydrochloride

ropinirole hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc. The primary component is Ropinirole Hydrochloride.

Product ID43547-268_363bab22-c254-4bf4-8b89-fdb974351de9
NDC43547-268
Product TypeHuman Prescription Drug
Proprietary Nameropinirole hydrochloride
Generic NameRopinirole Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-09-20
Marketing CategoryANDA / ANDA
Application NumberANDA078110
Labeler NameSOLCO HEALTHCARE US, LLC
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength0 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 43547-268-10

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-268-10)
Marketing Start Date2011-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43547-268-10 [43547026810]

ropinirole hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-20
Inactivation Date2020-01-31
Reactivation Date2020-04-08

NDC 43547-268-50 [43547026850]

ropinirole hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-09-20
Inactivation Date2020-01-31
Reactivation Date2020-04-08

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE.25 mg/1

OpenFDA Data

SPL SET ID:7734ef0b-584f-42dd-a8b5-adbdf4e4df93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312845
  • 312846
  • 312847
  • 314208
  • 312849
  • 562704
  • 283858

    • Pharmacological Class

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

    Medicade Reported Pricing

    43547026850 ROPINIROLE HCL 0.25 MG TABLET

    Pricing Unit: EA | Drug Type:

    43547026810 ROPINIROLE HCL 0.25 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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