| 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] |