NDC 43353-266

Ropinirole Hydrochloride

Ropinirole

Ropinirole Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Ropinirole Hydrochloride.

Product ID43353-266_137b8563-7235-4e5b-bcdf-68e788eb8d8b
NDC43353-266
Product TypeHuman Prescription Drug
Proprietary NameRopinirole Hydrochloride
Generic NameRopinirole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA078881
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-266-09

9000 TABLET in 1 BOTTLE, PLASTIC (43353-266-09)
Marketing Start Date2016-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-266-09 [43353026609]

Ropinirole Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078881
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-02

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:471a4163-9b09-425c-8736-961d26ab11c3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314208
  • 312845
  • 312846
  • 312847
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0615-7537Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7538Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7539Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7567Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-7536Ropinirole HydrochlorideRopinirole Hydrochloride
    0615-8189ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8190ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8191ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0615-8188ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0904-6374ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    0904-6373ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-794ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-793ropinirole hydrochlorideropinirole hydrochloride
    21695-798ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    21695-792ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    43353-265Ropinirole HydrochlorideRopinirole Hydrochloride
    43353-194ropinirole hydrochlorideropinirole hydrochloride
    43547-273ropinirole hydrochlorideropinirole hydrochloride
    43353-195ropinirole 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
    46708-031ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    46708-036ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    46708-033ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    46708-034ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    46708-035ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE
    50090-1330ropinirole hydrochlorideropinirole hydrochloride
    50090-3304ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE

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