| Product NDC: | 0085-1430 | 
| Proprietary Name: | TEMODAR | 
| Non Proprietary Name: | Temozolomide | 
| Active Ingredient(s): | 180 mg/1 & nbsp; Temozolomide | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | CAPSULE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0085-1430 | 
| Labeler Name: | Merck Sharp & Dohme Corp. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA021029 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 19990811 | 
| Package NDC: | 0085-1430-02 | 
| Package Description: | 1 BOTTLE, GLASS in 1 CARTON (0085-1430-02) > 14 CAPSULE in 1 BOTTLE, GLASS | 
| NDC Code | 0085-1430-02 | 
| Proprietary Name | TEMODAR | 
| Package Description | 1 BOTTLE, GLASS in 1 CARTON (0085-1430-02) > 14 CAPSULE in 1 BOTTLE, GLASS | 
| Product NDC | 0085-1430 | 
| 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 | 180 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |