"0378-5204-05" National Drug Code (NDC)

Montelukast Sodium 500 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-5204-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5204-05
Package Description500 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-5204-05)
Product NDC0378-5204
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMontelukast Sodium
Non-Proprietary NameMontelukast Sodium
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20120803
Marketing Category NameANDA
Application NumberANDA079142
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMONTELUKAST SODIUM
Strength4
Strength Unitmg/1
Pharmacy ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

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