| Product NDC: | 0085-1425 |
| Proprietary Name: | TEMODAR |
| Non Proprietary Name: | Temozolomide |
| Active Ingredient(s): | 140 mg/1 & nbsp; Temozolomide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0085-1425 |
| Labeler Name: | Merck Sharp & Dohme Corp. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021029 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19990811 |
| Package NDC: | 0085-1425-04 |
| Package Description: | 14 PACKET in 1 CARTON (0085-1425-04) > 1 CAPSULE in 1 PACKET (0085-1425-05) |
| NDC Code | 0085-1425-04 |
| Proprietary Name | TEMODAR |
| Package Description | 14 PACKET in 1 CARTON (0085-1425-04) > 1 CAPSULE in 1 PACKET (0085-1425-05) |
| Product NDC | 0085-1425 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Temozolomide |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 19990811 |
| Marketing Category Name | NDA |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | TEMOZOLOMIDE |
| Strength Number | 140 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |