NDC 62332-035

ROPINIROLE HYDROCHLORIDE

Ropinirole Hydrochloride

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

Product ID62332-035_852de55f-da70-42b7-a2be-1875623c4fee
NDC62332-035
Product TypeHuman Prescription Drug
Proprietary NameROPINIROLE HYDROCHLORIDE
Generic NameRopinirole Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-01-29
Marketing CategoryANDA / ANDA
Application NumberANDA090429
Labeler NameAlembic Pharmaceuticals Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 62332-035-30

30 TABLET, FILM COATED in 1 BOTTLE (62332-035-30)
Marketing Start Date2016-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62332-035-30 [62332003530]

ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090429
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-29

NDC 62332-035-31 [62332003531]

ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090429
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-29

NDC 62332-035-62 [62332003562]

ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090429
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-29
Marketing End Date2019-01-30

NDC 62332-035-91 [62332003591]

ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090429
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-29
Marketing End Date2019-01-30

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312845
  • 312846
  • 312847
  • 314208
  • 312849
  • 562704
  • 283858
    • UPC Code
  • 0362332035304
  • 0362332036301
  • 0362332030309
  • 0362332033300
  • 0362332034307
  • 0362332032303
  • 0362332031306

    • Pharmacological Class

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

    Medicade Reported Pricing

    62332003531 ROPINIROLE HCL 4 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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