Montelukast Sodium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Montelukast Sodium.
| Product ID | 71610-129_797baf6f-f318-4380-abac-4218838ce3bb |
| NDC | 71610-129 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Montelukast Sodium |
| Generic Name | Montelukast Sodium |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-08-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202468 |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Substance Name | MONTELUKAST SODIUM |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-09-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202468 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-04 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202468 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-08-22 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| MONTELUKAST SODIUM | 10 mg/1 |
| SPL SET ID: | 46b85c12-52bc-4768-a7c8-40b1546e9e0e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0259 | Montelukast Sodium | Montelukast Sodium |
| 0054-0288 | Montelukast Sodium | Montelukast Sodium |
| 0054-0289 | Montelukast Sodium | Montelukast Sodium |
| 0093-7424 | Montelukast Sodium | Montelukast Sodium |
| 0093-7425 | Montelukast Sodium | Montelukast Sodium |
| 68001-248 | montelukast sodium | montelukast sodium |
| 68071-4047 | Montelukast Sodium | Montelukast Sodium |
| 68071-4054 | Montelukast Sodium | Montelukast Sodium |
| 68071-3355 | Montelukast Sodium | Montelukast Sodium |
| 68084-875 | Montelukast Sodium | Montelukast Sodium |
| 68151-3494 | Montelukast Sodium | Montelukast Sodium |
| 68151-4186 | Montelukast Sodium | Montelukast Sodium |
| 68151-3498 | Montelukast Sodium | Montelukast Sodium |
| 68151-4338 | Montelukast Sodium | Montelukast Sodium |
| 68462-392 | montelukast sodium | montelukast sodium |
| 68788-6410 | Montelukast Sodium | Montelukast Sodium |
| 68788-6946 | Montelukast Sodium | Montelukast Sodium |
| 68788-8988 | Montelukast Sodium | Montelukast Sodium |
| 68788-7064 | Montelukast Sodium | Montelukast Sodium |
| 68788-9438 | Montelukast Sodium | Montelukast Sodium |
| 68788-9439 | Montelukast Sodium | Montelukast Sodium |
| 70436-091 | Montelukast Sodium | Montelukast Sodium |
| 70436-090 | Montelukast Sodium | Montelukast Sodium |
| 70518-0172 | Montelukast Sodium | Montelukast Sodium |
| 70518-0294 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
| 70518-0684 | Montelukast Sodium | Montelukast Sodium |
| 70518-0331 | Montelukast Sodium | Montelukast Sodium |
| 70518-0805 | Montelukast Sodium | Montelukast Sodium |
| 70518-1075 | Montelukast Sodium | Montelukast Sodium |
| 70518-1085 | Montelukast Sodium | Montelukast Sodium |
| 70518-1784 | Montelukast Sodium | Montelukast Sodium |
| 0603-4655 | Montelukast Sodium | Montelukast Sodium |
| 70934-202 | Montelukast Sodium | Montelukast Sodium |
| 71205-128 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
| 0603-4653 | Montelukast Sodium | Montelukast Sodium |
| 0603-4654 | Montelukast Sodium | Montelukast Sodium |
| 71335-0629 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
| 71335-0611 | Montelukast Sodium | Montelukast Sodium |
| 71205-181 | montelukast sodium | montelukast sodium |
| 71335-0514 | Montelukast Sodium | Montelukast Sodium |
| 71335-0620 | Montelukast Sodium | Montelukast Sodium |
| 71335-0301 | Montelukast Sodium | Montelukast Sodium |
| 71610-129 | Montelukast Sodium | Montelukast Sodium |
| 71610-026 | Montelukast Sodium | Montelukast Sodium |
| 71610-051 | Montelukast Sodium | Montelukast Sodium |
| 0615-7748 | Montelukast Sodium | Montelukast Sodium |
| 0615-7983 | Montelukast Sodium | Montelukast Sodium |
| 0904-6529 | Montelukast Sodium | Montelukast Sodium |
| 13668-079 | Montelukast Sodium | Montelukast Sodium |
| 13668-081 | Montelukast Sodium | Montelukast Sodium |