Zafirlukast is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Zafirlukast.
| Product ID | 50268-805_6e14570e-933d-7f1b-e053-2991aa0aa8a0 |
| NDC | 50268-805 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zafirlukast |
| Generic Name | Zafirlukast |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-09-15 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090372 |
| Labeler Name | AvPAK |
| Substance Name | ZAFIRLUKAST |
| Active Ingredient Strength | 20 mg/1 |
| Pharm Classes | Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Leukotriene Receptor Antagonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-09-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090372 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-09-15 |
| Marketing Category | ANDA |
| Application Number | ANDA090372 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-09-15 |
| Ingredient | Strength |
|---|---|
| ZAFIRLUKAST | 20 mg/1 |
| SPL SET ID: | 5e52e5ca-0cab-48c3-993e-f737e978a8c1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| 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 |