"0378-3979-05" National Drug Code (NDC)

Paliperidone 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3979-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3979-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3979-05)
Product NDC0378-3979
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePaliperidone
Non-Proprietary NamePaliperidone
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150924
Marketing Category NameANDA
Application NumberANDA203802
ManufacturerMylan Pharmaceuticals Inc.
Substance NamePALIPERIDONE
Strength3
Strength Unitmg/1
Pharmacy ClassesAtypical Antipsychotic [EPC]

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