"0054-0289-13" National Drug Code (NDC)

Montelukast Sodium 30 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-13)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0289-13
Package Description30 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-13)
Product NDC0054-0289
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMontelukast Sodium
Non-Proprietary NameMontelukast Sodium
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20120803
Marketing Category NameANDA
Application NumberANDA091128
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameMONTELUKAST SODIUM
Strength5
Strength Unitmg/1
Pharmacy ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

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