NDC 64679-773

Ropinirole Hydrochloride

Ropinirole Hydrochloride

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

Product ID64679-773_16dc7f02-9997-458e-b829-105cacbcbeab
NDC64679-773
Product TypeHuman Prescription Drug
Proprietary NameRopinirole Hydrochloride
Generic NameRopinirole Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-08-15
Marketing CategoryANDA / ANDA
Application NumberANDA091395
Labeler NameWockhardt USA LLC.
Substance NameROPINIROLE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 64679-773-05

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-773-05)
Marketing Start Date2012-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64679-773-05 [64679077305]

Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-15
Inactivation Date2020-01-31

NDC 64679-773-02 [64679077302]

Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-15
Inactivation Date2020-01-31

NDC 64679-773-04 [64679077304]

Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-15
Inactivation Date2020-01-31

NDC 64679-773-03 [64679077303]

Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-15
Inactivation Date2020-01-31

NDC 64679-773-01 [64679077301]

Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091395
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ROPINIROLE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:6c24b96c-7d8d-494a-b7cd-49fe6138a66d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 799056
  • 799054
  • 799055
  • 848582
  • 824959
    • UPC Code
  • 0364679774038
  • 0364679773024
  • 0364679775028
  • 0364679776056
  • 0026711000061

    • 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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