"0378-5504-01" National Drug Code (NDC)

Ropinirole 100 TABLET in 1 BOTTLE, PLASTIC (0378-5504-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5504-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (0378-5504-01)
Product NDC0378-5504
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRopinirole
Non-Proprietary NameRopinirole
Dosage FormTABLET
UsageORAL
Start Marketing Date20080505
End Marketing Date20230430
Marketing Category NameANDA
Application NumberANDA078881
ManufacturerMylan Pharmaceuticals Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Strength4
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]

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