"0378-1011-01" National Drug Code (NDC)

Quetiapine Fumarate 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1011-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-1011-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1011-01)
Product NDC0378-1011
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameQuetiapine Fumarate
Non-Proprietary NameQuetiapine Fumarate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120327
Marketing Category NameANDA
Application NumberANDA090323
ManufacturerMylan Pharmaceuticals Inc.
Substance NameQUETIAPINE FUMARATE
Strength25
Strength Unitmg/1
Pharmacy ClassesAtypical Antipsychotic [EPC]

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