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NDC 65862-0568-05 Montelukast Sodium 5 mg/1 Details
Montelukast Sodium 5 mg/1
Montelukast Sodium is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is MONTELUKAST SODIUM.
MedlinePlus Drug Summary
Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older. Montelukast is also used to treat the symptoms of seasonal (occurs only at certain times of the year), allergic rhinitis (a condition associated with sneezing and stuffy, runny or itchy nose) in adults and children 2 years of age and older, and perennial (occurs all year round) allergic rhinitis in adults and children 6 months of age and older. Montelukast should be used to treat seasonal or perennial allergic rhinitis only in adults and children who cannot be treated with other medications. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.
Related Packages: 65862-0568-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Montelukast
Product Information
| NDC | 65862-0568 |
|---|---|
| Product ID | 65862-568_05310d45-6b7e-478d-8412-82f1714cc317 |
| Associated GPIs | 44505050100520 |
| GCN Sequence Number | 037003 |
| GCN Sequence Number Description | montelukast sodium TAB CHEW 5 MG ORAL |
| HIC3 | Z4B |
| HIC3 Description | LEUKOTRIENE RECEPTOR ANTAGONISTS |
| GCN | 94440 |
| HICL Sequence Number | 016911 |
| HICL Sequence Number Description | MONTELUKAST SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Montelukast Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Montelukast Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | MONTELUKAST SODIUM |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202096 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0568-05 (65862056805)
| NDC Package Code | 65862-568-05 |
|---|---|
| Billing NDC | 65862056805 |
| Package | 500 TABLET, CHEWABLE in 1 BOTTLE (65862-568-05) |
| Marketing Start Date | 2012-08-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |