"0378-6045-01" National Drug Code (NDC)

Risperidone 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-6045-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6045-01
Package Description100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-6045-01)
Product NDC0378-6045
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRisperidone
Non-Proprietary NameRisperidone
Dosage FormTABLET, ORALLY DISINTEGRATING
UsageORAL
Start Marketing Date20130401
Marketing Category NameANDA
Application NumberANDA091537
ManufacturerMylan Pharmaceuticals Inc.
Substance NameRISPERIDONE
Strength2
Strength Unitmg/1
Pharmacy ClassesAtypical Antipsychotic [EPC]

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