"68382-475-06" National Drug Code (NDC)

Pramipexole Dihydrochloride 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-475-06)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-475-06
Package Description30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-475-06)
Product NDC68382-475
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePramipexole Dihydrochloride
Non-Proprietary NamePramipexole Dihydrochloride
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20180424
Marketing Category NameANDA
Application NumberANDA202891
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NamePRAMIPEXOLE DIHYDROCHLORIDE
Strength.75
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]

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