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] |