NDC 68180-169
ZILEUTON
Zileuton
ZILEUTON is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Zileuton.
| Product ID | 68180-169_5ccc51b9-399b-4c7e-b2e4-1bde256a0aee |
| NDC | 68180-169 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ZILEUTON |
| Generic Name | Zileuton |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-08-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211972 |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Substance Name | ZILEUTON |
| Active Ingredient Strength | 600 1/1 |
| Pharm Classes | 5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |