| NDC Code | 68462-392-05 | 
                
                    | Proprietary Name | montelukast sodium | 
                
                    | Package Description | 500 TABLET, FILM COATED in 1 BOTTLE (68462-392-05) | 
                
                    | Product NDC | 68462-392 | 
                
                    | Product Type Name | HUMAN PRESCRIPTION DRUG | 
                
                    | Non Proprietary Name | montelukast sodium | 
                
                    | Dosage Form Name | TABLET, FILM COATED | 
                
                    | Route Name | ORAL | 
                
                    | Start Marketing Date | 20120803 | 
                
                    | Marketing Category Name | ANDA | 
                
                    | Labeler Name | Glenmark Generics Inc., USA | 
                
                    | Substance Name | MONTELUKAST SODIUM | 
                
                    | Strength Number | 10 | 
                
                    | Strength Unit | mg/1 | 
                
                    | Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |