Zafirlukast is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Zafirlukast.
| Product ID | 16571-654_4b144769-47cc-402a-a061-a80454eb245b |
| NDC | 16571-654 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zafirlukast |
| Generic Name | Zafirlukast |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-08-25 |
| Marketing Category | ANDA / |
| Application Number | ANDA204928 |
| Labeler Name | Rising Pharmaceuticals, Inc. |
| Substance Name | ZAFIRLUKAST |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-08-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0904-6646 | Zafirlukast | zafirlukast |
| 16571-654 | Zafirlukast | Zafirlukast |
| 16571-655 | Zafirlukast | Zafirlukast Tablets |
| 31722-007 | Zafirlukast | Zafirlukast |
| 31722-008 | Zafirlukast | Zafirlukast |
| 49884-549 | Zafirlukast | zafirlukast |
| 49884-554 | Zafirlukast | zafirlukast |
| 50268-805 | Zafirlukast | Zafirlukast |
| 55111-625 | Zafirlukast | Zafirlukast |
| 55111-626 | Zafirlukast | Zafirlukast |
| 63629-2102 | Zafirlukast | zafirlukast |
| 64380-187 | Zafirlukast | zafirlukast |
| 64380-188 | Zafirlukast | zafirlukast |
| 68084-059 | Zafirlukast | Zafirlukast |
| 68151-1977 | Zafirlukast | Zafirlukast |
| 49884-010 | ACCOLATE | zafirlukast |
| 49884-011 | ACCOLATE | zafirlukast |
| 49884-589 | Accolate | zafirlukast |
| 49884-590 | Accolate | zafirlukast |
| 53808-0203 | ACCOLATE | Zafirlukast |
| 64380-177 | ACCOLATE | Zafirlukast |
| 64380-178 | ACCOLATE | Zafirlukast |