NDC 64380-189
Zileuton
Zileuton
Zileuton is a Oral Tablet, Multilayer, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Zileuton.
| Product ID | 64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1 |
| NDC | 64380-189 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zileuton |
| Generic Name | Zileuton |
| Dosage Form | Tablet, Multilayer, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-10-15 |
| Marketing Category | ANDA / |
| Application Number | ANDA212670 |
| Labeler Name | Strides Pharma Science Limited |
| Substance Name | ZILEUTON |
| Active Ingredient Strength | 600 mg/1 |
| Pharm Classes | 5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |