| Product NDC: | 63323-194 |
| Proprietary Name: | Idarubicin Hydrochloride |
| Non Proprietary Name: | IDARUBICIN HYDROCHLORIDE |
| Active Ingredient(s): | 1 mg/mL & nbsp; IDARUBICIN HYDROCHLORIDE |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-194 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA065440 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090811 |
| Package NDC: | 63323-194-05 |
| Package Description: | 1 VIAL in 1 CARTON (63323-194-05) > 5 mL in 1 VIAL |
| NDC Code | 63323-194-05 |
| Proprietary Name | Idarubicin Hydrochloride |
| Package Description | 1 VIAL in 1 CARTON (63323-194-05) > 5 mL in 1 VIAL |
| Product NDC | 63323-194 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | IDARUBICIN HYDROCHLORIDE |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20090811 |
| Marketing Category Name | ANDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | IDARUBICIN HYDROCHLORIDE |
| Strength Number | 1 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] |