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Montelukast Sodium
Montelukast Sodium - 0054-0289-22 - (Montelukast Sodium)
Drug Information of Montelukast Sodium
| Product NDC: | 0054-0289 |
| 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) |
Labeler Information of Montelukast Sodium
| Product NDC: | 0054-0289 |
| Labeler Name: | Roxane Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA091128 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120803 |
Package Information of Montelukast Sodium
| Package NDC: | 0054-0289-22 |
| Package Description: | 90 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-22) |
NDC Information of Montelukast Sodium
| NDC Code | 0054-0289-22 |
| Proprietary Name | Montelukast Sodium |
| Package Description | 90 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-22) |
| Product NDC | 0054-0289 |
| 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 | Roxane Laboratories, Inc. |
| Substance Name | MONTELUKAST SODIUM |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |
