"0378-5201-10" National Drug Code (NDC)

Montelukast Sodium 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5201-10)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5201-10
Package Description1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5201-10)
Product NDC0378-5201
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMontelukast Sodium
Non-Proprietary NameMontelukast Sodium
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120803
Marketing Category NameANDA
Application NumberANDA079103
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMONTELUKAST SODIUM
Strength10
Strength Unitmg/1
Pharmacy ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

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