| Product NDC: | 0085-1381 |
| Proprietary Name: | TEMODAR |
| Non Proprietary Name: | Temozolomide |
| Active Ingredient(s): | 2.5 mg/mL & nbsp; Temozolomide |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0085-1381 |
| Labeler Name: | Merck Sharp & Dohme Corp. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022277 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090227 |
| Package NDC: | 0085-1381-01 |
| Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) > 40 mL in 1 VIAL, SINGLE-USE |
| NDC Code | 0085-1381-01 |
| Proprietary Name | TEMODAR |
| Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) > 40 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 0085-1381 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Temozolomide |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20090227 |
| Marketing Category Name | NDA |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | TEMOZOLOMIDE |
| Strength Number | 2.5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |