"42291-579-50" National Drug Code (NDC)

Paroxetine Hydrochloride 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-579-50)
(AvKARE, Inc.)

NDC Code42291-579-50
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-579-50)
Product NDC42291-579
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameParoxetine Hydrochloride
Non-Proprietary NameParoxetine Hydrochloride
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20161102
Marketing Category NameANDA
Application NumberANDA204744
ManufacturerAvKARE, Inc.
Substance NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE
Strength12.5
Strength Unitmg/1
Pharmacy ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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