| NDC Code | 68727-712-01 |
|---|
| Package Description | 8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01) |
|---|
| Product NDC | 68727-712 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Zepzelca |
|---|
| Non-Proprietary Name | Lurbinectedin |
|---|
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
|---|
| Usage | INTRAVENOUS |
|---|
| Start Marketing Date | 20200615 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA213702 |
|---|
| Manufacturer | Jazz Pharmaceuticals, Inc. |
|---|
| Substance Name | LURBINECTEDIN |
|---|
| Strength | .5 |
|---|
| Strength Unit | mg/mL |
|---|
| Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |
|---|