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Mylotarg
Mylotarg - 0008-4510-01 - (gemtuzumab ozogamicin)
Drug Information of Mylotarg
| Product NDC: | 0008-4510 |
| Proprietary Name: | Mylotarg |
| Non Proprietary Name: | gemtuzumab ozogamicin |
| Active Ingredient(s): | 5 mg/5mL & nbsp; gemtuzumab ozogamicin |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Mylotarg
| Product NDC: | 0008-4510 |
| Labeler Name: | Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021174 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20000530 |
Package Information of Mylotarg
| Package NDC: | 0008-4510-01 |
| Package Description: | 5 mL in 1 VIAL, GLASS (0008-4510-01) |
NDC Information of Mylotarg
| NDC Code | 0008-4510-01 |
| Proprietary Name | Mylotarg |
| Package Description | 5 mL in 1 VIAL, GLASS (0008-4510-01) |
| Product NDC | 0008-4510 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | gemtuzumab ozogamicin |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20000530 |
| Marketing Category Name | NDA |
| Labeler Name | Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. |
| Substance Name | GEMTUZUMAB OZOGAMICIN |
| Strength Number | 5 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | CD33-directed Cytotoxin [EPC] |
