"0378-4386-91" National Drug Code (NDC)

Naproxen And Esomeprazole Magnesium 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4386-91)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4386-91
Package Description60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4386-91)
Product NDC0378-4386
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNaproxen And Esomeprazole Magnesium
Non-Proprietary NameNaproxen And Esomeprazole Magnesium
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20211122
End Marketing Date20231031
Marketing Category NameANDA
Application NumberANDA204920
ManufacturerMylan Pharmaceuticals Inc.
Substance NameESOMEPRAZOLE MAGNESIUM; NAPROXEN
Strength20; 500
Strength Unitmg/1; mg/1
Pharmacy ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]

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