Montelukast is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Montelukast Sodium.
| Product ID | 0781-5555_419ac695-fc60-4b5b-ab3e-36820c60729b |
| NDC | 0781-5555 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Montelukast |
| Generic Name | Montelukast |
| Dosage Form | Tablet, Chewable |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-08-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091414 |
| Labeler Name | Sandoz Inc |
| Substance Name | MONTELUKAST SODIUM |
| Active Ingredient Strength | 5 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 | 2012-08-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091414 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-08-03 |
| Marketing Category | ANDA |
| Application Number | ANDA091414 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-08-03 |
| Marketing Category | ANDA |
| Application Number | ANDA091414 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-03 |
| Marketing Category | ANDA |
| Application Number | ANDA091414 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-03 |
| Marketing Category | ANDA |
| Application Number | ANDA091414 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-03 |
| Marketing Category | ANDA |
| Application Number | ANDA091414 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-08-03 |
| Ingredient | Strength |
|---|---|
| MONTELUKAST SODIUM | 5 mg/1 |
| SPL SET ID: | 6d69e73a-76cb-4ece-9cf9-e9adb4f523b4 |
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| RxNorm Concept Unique ID - RxCUI | |
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