"0378-5501-10" National Drug Code (NDC)

Ropinirole Hydrochloride 1000 TABLET in 1 BOTTLE, PLASTIC (0378-5501-10)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5501-10
Package Description1000 TABLET in 1 BOTTLE, PLASTIC (0378-5501-10)
Product NDC0378-5501
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRopinirole Hydrochloride
Non-Proprietary NameRopinirole
Dosage FormTABLET
UsageORAL
Start Marketing Date20080505
Marketing Category NameANDA
Application NumberANDA078881
ManufacturerMylan Pharmaceuticals Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Strength1
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

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