 
                        | Product NDC: | 65862-568 | 
| Proprietary Name: | Montelukast Sodium | 
| Non Proprietary Name: | Montelukast Sodium | 
| Active Ingredient(s): | 5 mg/1 & nbsp; Montelukast Sodium | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, CHEWABLE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 65862-568 | 
| Labeler Name: | Aurobindo Pharma Limited | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA202096 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20120803 | 
| Package NDC: | 65862-568-05 | 
| Package Description: | 500 TABLET, CHEWABLE in 1 BOTTLE (65862-568-05) | 
| NDC Code | 65862-568-05 | 
| Proprietary Name | Montelukast Sodium | 
| Package Description | 500 TABLET, CHEWABLE in 1 BOTTLE (65862-568-05) | 
| Product NDC | 65862-568 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Montelukast Sodium | 
| Dosage Form Name | TABLET, CHEWABLE | 
| Route Name | ORAL | 
| Start Marketing Date | 20120803 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Aurobindo Pharma Limited | 
| Substance Name | MONTELUKAST SODIUM | 
| Strength Number | 5 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |