| Product NDC: | 53150-336 |
| Proprietary Name: | Idarubicin Hydrochloride |
| Non Proprietary Name: | Idarubicin Hydrochloride |
| Active Ingredient(s): | 5 mg/5mL & nbsp; Idarubicin Hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 53150-336 |
| Labeler Name: | Amneal-Agila, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA200144 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130430 |
| Package NDC: | 53150-336-01 |
| Package Description: | 1 VIAL, SINGLE-DOSE in 1 CARTON (53150-336-01) > 5 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 53150-336-01 |
| Proprietary Name | Idarubicin Hydrochloride |
| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (53150-336-01) > 5 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 53150-336 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Idarubicin Hydrochloride |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20130430 |
| Marketing Category Name | ANDA |
| Labeler Name | Amneal-Agila, LLC |
| Substance Name | IDARUBICIN HYDROCHLORIDE |
| Strength Number | 5 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] |