"0378-4094-93" National Drug Code (NDC)

Ropinirole Hydrochloride 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4094-93)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4094-93
Package Description30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4094-93)
Product NDC0378-4094
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRopinirole Hydrochloride
Non-Proprietary NameRopinirole Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20121016
End Marketing Date20180831
Marketing Category NameANDA
Application NumberANDA200462
ManufacturerMylan Pharmaceuticals Inc.
Substance NameROPINIROLE HYDROCHLORIDE
Strength12
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

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