"68382-198-10" National Drug Code (NDC)

Pramipexole Dihydrochloride 1000 TABLET in 1 BOTTLE (68382-198-10)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-198-10
Package Description1000 TABLET in 1 BOTTLE (68382-198-10)
Product NDC68382-198
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePramipexole Dihydrochloride
Non-Proprietary NamePramipexole Dihydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20100710
Marketing Category NameANDA
Application NumberANDA078920
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Strength.5
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]

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