"68382-478-77" National Drug Code (NDC)

Pramipexole Dihydrochloride 10 BLISTER PACK in 1 CARTON (68382-478-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-478-30)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-478-77
Package Description10 BLISTER PACK in 1 CARTON (68382-478-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-478-30)
Product NDC68382-478
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
Strength4.5
Strength Unitmg/1
Pharmacy ClassesDopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]

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