| Product NDC: | 55390-207 |
| Proprietary Name: | Epirubicin hydrochloride |
| Non Proprietary Name: | Epirubicin hydrochloride |
| Active Ingredient(s): | 2 mg/mL & nbsp; Epirubicin hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55390-207 |
| Labeler Name: | Bedford Laboratories |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA065289 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20070807 |
| Package NDC: | 55390-207-01 |
| Package Description: | 1 VIAL, PLASTIC in 1 BOX (55390-207-01) > 25 mL in 1 VIAL, PLASTIC |
| NDC Code | 55390-207-01 |
| Proprietary Name | Epirubicin hydrochloride |
| Package Description | 1 VIAL, PLASTIC in 1 BOX (55390-207-01) > 25 mL in 1 VIAL, PLASTIC |
| Product NDC | 55390-207 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Epirubicin hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20070807 |
| Marketing Category Name | ANDA |
| Labeler Name | Bedford Laboratories |
| Substance Name | EPIRUBICIN HYDROCHLORIDE |
| Strength Number | 2 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] |