"53002-5441-1" National Drug Code (NDC)

Montelukast Sodium 30 TABLET, FILM COATED in 1 BOTTLE (53002-5441-1)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-5441-1
Package Description30 TABLET, FILM COATED in 1 BOTTLE (53002-5441-1)
Product NDC53002-5441
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMontelukast Sodium
Non-Proprietary NameMontelukast Sodium
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20160101
Marketing Category NameANDA
Application NumberANDA204290
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameMONTELUKAST SODIUM
Strength10
Strength Unitmg/1
Pharmacy ClassesLeukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]

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