Montelukast is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by International Laboratories, Llc. The primary component is Montelukast Sodium.
| Product ID | 54458-890_027c648e-3e87-4458-9973-d305db3aefed |
| NDC | 54458-890 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Montelukast |
| Generic Name | Montelukast |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-10-04 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078605 |
| Labeler Name | International Laboratories, LLC |
| Substance Name | MONTELUKAST SODIUM |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2013-10-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA078605 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-10-04 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| MONTELUKAST SODIUM | 10 mg/1 |
| SPL SET ID: | bfa9d526-6c07-4391-96a7-e8c6d6e4b573 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9649 | MONTELUKAST | MONTELUKAST |
| 0143-9650 | MONTELUKAST | MONTELUKAST |
| 0143-9651 | MONTELUKAST | MONTELUKAST |
| 0781-5554 | Montelukast | Montelukast |
| 0781-5555 | Montelukast | Montelukast |
| 0781-5560 | Montelukast | Montelukast |
| 0904-6808 | Montelukast | Montelukast |
| 31722-726 | Montelukast | Montelukast |
| 33342-102 | Montelukast | Montelukast |
| 50090-6108 | Montelukast | Montelukast |
| 50268-556 | Montelukast | Montelukast |
| 51128-501 | MONTELUKAST | MONTELUKAST |
| 51128-502 | MONTELUKAST | MONTELUKAST |
| 51128-503 | MONTELUKAST | MONTELUKAST |
| 54458-890 | Montelukast | Montelukast |
| 55154-8075 | Montelukast | Montelukast |
| 63187-626 | MONTELUKAST | MONTELUKAST |
| 63629-4886 | Montelukast | Montelukast |
| 68001-361 | Montelukast | Montelukast |
| 68071-1652 | MONTELUKAST | MONTELUKAST |
| 68071-4034 | Montelukast | Montelukast |
| 68645-560 | Montelukast | Montelukast |
| 68788-7387 | MONTELUKAST | MONTELUKAST |
| 69452-105 | MONTELUKAST | MONTELUKAST |
| 69452-107 | MONTELUKAST | MONTELUKAST |
| 69452-106 | MONTELUKAST | MONTELUKAST |
| 70518-1031 | Montelukast | Montelukast |
| 70518-2603 | Montelukast | Montelukast |
| 27241-017 | MONTELUKAST SODIUM | MONTELUKAST |
| 53217-357 | MONTELUKAST SODIUM | MONTELUKAST |