"43353-195-09" National Drug Code (NDC)

Ropinirole Hydrochloride 9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-195-09)
(Aphena Pharma Solutions - Tennessee, LLC)

NDC Code43353-195-09
Package Description9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-195-09)
Product NDC43353-195
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRopinirole Hydrochloride
Non-Proprietary NameRopinirole Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20110920
Marketing Category NameANDA
Application NumberANDA078110
ManufacturerAphena Pharma Solutions - Tennessee, LLC
Substance NameROPINIROLE HYDROCHLORIDE
Strength.5
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

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