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NDC 59651-0291-60 Zafirlukast 10 mg/1 Details
Zafirlukast 10 mg/1
Zafirlukast is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is ZAFIRLUKAST.
MedlinePlus Drug Summary
Zafirlukast is used to prevent asthma symptoms. Zafirlukast is in a class of medications called leukotriene receptor antagonists (LTRAs). It works by blocking the action of certain natural substances that cause swelling and tightening of the airways.
Related Packages: 59651-0291-60Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Zafirlukast
Product Information
| NDC | 59651-0291 |
|---|---|
| Product ID | 59651-291_8bdb47c5-9d19-4d59-94c8-62c117525e7f |
| Associated GPIs | |
| GCN Sequence Number | 043557 |
| GCN Sequence Number Description | zafirlukast TABLET 10 MG ORAL |
| HIC3 | Z4B |
| HIC3 Description | LEUKOTRIENE RECEPTOR ANTAGONISTS |
| GCN | 52271 |
| HICL Sequence Number | 011815 |
| HICL Sequence Number Description | ZAFIRLUKAST |
| Brand/Generic | Generic |
| Proprietary Name | Zafirlukast |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zafirlukast |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | ZAFIRLUKAST |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213163 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59651-0291-60 (59651029160)
| NDC Package Code | 59651-291-60 |
|---|---|
| Billing NDC | 59651029160 |
| Package | 60 TABLET, FILM COATED in 1 BOTTLE (59651-291-60) |
| Marketing Start Date | 2023-11-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |