"0378-2005-05" National Drug Code (NDC)

Paroxetine Hydrochloride 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-2005-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-05)
Product NDC0378-2005
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameParoxetine Hydrochloride
Non-Proprietary NameParoxetine Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20110505
Marketing Category NameANDA
Application NumberANDA091427
ManufacturerMylan Pharmaceuticals Inc.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Strength37.5
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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