"0378-3816-01" National Drug Code (NDC)

Clozapine 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3816-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3816-01
Package Description100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3816-01)
Product NDC0378-3816
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameClozapine
Non-Proprietary NameClozapine
Dosage FormTABLET, ORALLY DISINTEGRATING
UsageORAL
Start Marketing Date20230816
Marketing Category NameANDA
Application NumberANDA201824
ManufacturerMylan Pharmaceuticals Inc.
Substance NameCLOZAPINE
Strength150
Strength Unitmg/1
Pharmacy ClassesAtypical Antipsychotic [EPC]

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