"0378-4093-77" National Drug Code (NDC)

Ropinirole Hydrochloride 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4093-77)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4093-77
Package Description90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4093-77)
Product NDC0378-4093
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRopinirole Hydrochloride
Non-Proprietary NameRopinirole Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20121016
Marketing Category NameANDA
Application NumberANDA200462
ManufacturerMylan Pharmaceuticals Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Strength8
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

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