NDC 0904-6373

ROPINIROLE HYDROCHLORIDE

Ropinirole Hydrochloride

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

Product ID0904-6373_3c2a6a36-196a-4ca3-9e9a-ef62272333ba
NDC0904-6373
Product TypeHuman Prescription Drug
Proprietary NameROPINIROLE HYDROCHLORIDE
Generic NameRopinirole Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA090429
Labeler NameMajor Pharmaceuticals
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength0 mg/1
Pharm ClassesDopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0904-6373-61

100 BLISTER PACK in 1 CARTON (0904-6373-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2014-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6373-61 [00904637361]

ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090429
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-01

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE.25 mg/1

OpenFDA Data

SPL SET ID:e7ef58c0-73ba-4af2-b82b-a33954ec44df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314208
  • 312845
  • 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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