| Product NDC: | 54868-4142 |
| Proprietary Name: | TEMODAR |
| Non Proprietary Name: | Temozolomide |
| Active Ingredient(s): | 20 mg/1 & nbsp; Temozolomide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-4142 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021029 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20050629 |
| Package NDC: | 54868-4142-4 |
| Package Description: | 40 CAPSULE in 1 BOTTLE (54868-4142-4) |
| NDC Code | 54868-4142-4 |
| Proprietary Name | TEMODAR |
| Package Description | 40 CAPSULE in 1 BOTTLE (54868-4142-4) |
| Product NDC | 54868-4142 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Temozolomide |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20050629 |
| Marketing Category Name | NDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | TEMOZOLOMIDE |
| Strength Number | 20 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |