Zafirlukast is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Zafirlukast.
| Product ID | 49884-549_182c9f01-ed0a-455c-b365-07bc37412958 |
| NDC | 49884-549 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zafirlukast |
| Generic Name | Zafirlukast |
| Dosage Form | Tablet, Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-11-19 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020547 |
| Labeler Name | Par Pharmaceutical, 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 | 2010-11-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA020547 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-11-19 |
| Ingredient | Strength |
|---|---|
| ZAFIRLUKAST | 10 mg/1 |
| SPL SET ID: | 0262e192-94f4-423d-a58e-bb374dc106fe |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| 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 |