| Product NDC: | 0088-1111 |
| Proprietary Name: | Nilandron |
| Non Proprietary Name: | Nilutamide |
| Active Ingredient(s): | 150 mg/1 & nbsp; Nilutamide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0088-1111 |
| Labeler Name: | sanofi-aventis U.S. LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020169 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19960919 |
| Package NDC: | 0088-1111-14 |
| Package Description: | 30 TABLET in 1 BOX (0088-1111-14) |
| NDC Code | 0088-1111-14 |
| Proprietary Name | Nilandron |
| Package Description | 30 TABLET in 1 BOX (0088-1111-14) |
| Product NDC | 0088-1111 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Nilutamide |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 19960919 |
| Marketing Category Name | NDA |
| Labeler Name | sanofi-aventis U.S. LLC |
| Substance Name | NILUTAMIDE |
| Strength Number | 150 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] |