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] |