"43353-879-09" National Drug Code (NDC)

Montelukast Sodium 9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-879-09)
(Aphena Pharma Solutions - Tennessee, LLC)

NDC Code43353-879-09
Package Description9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-879-09)
Product NDC43353-879
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMontelukast Sodium
Non-Proprietary NameMontelukast Sodium
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120810
Marketing Category NameANDA
Application NumberANDA201522
ManufacturerAphena Pharma Solutions - Tennessee, LLC
Substance NameMONTELUKAST SODIUM
Strength10
Strength Unitmg/1
Pharmacy ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

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