Montelukast is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Camber Pharmaceuticals, Inc.. The primary component is Montelukast Sodium.
| Product ID | 31722-726_24e80b6e-b3cf-4513-8461-6d5aa66abff3 | 
| NDC | 31722-726 | 
| Product Type | Human Prescription Drug | 
| Proprietary Name | Montelukast | 
| Generic Name | Montelukast | 
| Dosage Form | Tablet, Film Coated | 
| Route of Administration | ORAL | 
| Marketing Start Date | 2014-09-10 | 
| Marketing Category | ANDA / ANDA | 
| Application Number | ANDA202843 | 
| Labeler Name | Camber Pharmaceuticals, Inc. | 
| 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 | 2021-12-31 | 
| Marketing Start Date | 2014-09-10 | 
| NDC Exclude Flag | N | 
| Sample Package? | N | 
| Marketing Category | ANDA | 
| Application Number | ANDA202843 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Marketing Start Date | 2014-09-10 | 
| Marketing Category | ANDA | 
| Application Number | ANDA202843 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Marketing Start Date | 2014-09-10 | 
| Marketing Category | ANDA | 
| Application Number | ANDA202843 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Billing Unit | EA | 
| Marketing Start Date | 2014-09-10 | 
| Marketing Category | ANDA | 
| Application Number | ANDA202843 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Marketing Start Date | 2014-09-10 | 
| Marketing Category | ANDA | 
| Application Number | ANDA202843 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Billing Unit | EA | 
| Marketing Start Date | 2014-09-10 | 
| Marketing Category | ANDA | 
| Application Number | ANDA202843 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Billing Unit | EA | 
| Marketing Start Date | 2014-09-10 | 
| Ingredient | Strength | 
|---|---|
| MONTELUKAST SODIUM | 10 mg/1 | 
| SPL SET ID: | 97a682c2-7e00-4d07-a5ac-4436c977f842 | 
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code | 
| 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 |