NDC 55648-172

Ropinirole Hydrochloride

Ropinirole Hydrochloride

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

Product ID55648-172_04e661d1-6156-43d0-abbd-64be8eca1666
NDC55648-172
Product TypeHuman Prescription Drug
Proprietary NameRopinirole Hydrochloride
Generic NameRopinirole Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-05-29
Marketing CategoryANDA / ANDA
Application NumberANDA079050
Labeler NameWockhardt Limited
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55648-172-02

100 TABLET, FILM COATED in 1 BOTTLE (55648-172-02)
Marketing Start Date2008-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-172-01 [55648017201]

Ropinirole Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-29
Inactivation Date2020-01-31

NDC 55648-172-04 [55648017204]

Ropinirole Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-29
Inactivation Date2020-01-31

NDC 55648-172-03 [55648017203]

Ropinirole Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-29
Inactivation Date2020-01-31

NDC 55648-172-02 [55648017202]

Ropinirole Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA079050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-05-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:414cd6c4-4926-4dfc-93c4-f04f4b7eeac3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312845
  • 312846
  • 312847
  • 314208
  • 312849
  • 562704
  • 283858
    • UPC Code
  • 0364679154021
  • 0364679177020
  • 0364679172032

    • 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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