"55648-775-05" National Drug Code (NDC)

Ropinirole Hydrochloride 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-775-05)
(Wockhardt Limited)

NDC Code55648-775-05
Package Description100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55648-775-05)
Product NDC55648-775
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRopinirole Hydrochloride
Non-Proprietary NameRopinirole Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20120815
Marketing Category NameANDA
Application NumberANDA091395
ManufacturerWockhardt Limited
Substance NameROPINIROLE HYDROCHLORIDE
Strength12
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

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