Idarubicin Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Idarubicin Hydrochloride.
| Product ID | 63323-194_23c8614b-c992-4842-9807-c5681c099546 |
| NDC | 63323-194 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Idarubicin Hydrochloride |
| Generic Name | Idarubicin Hydrochloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2009-08-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA065440 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | IDARUBICIN HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2009-08-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA065440 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-08-11 |
| Marketing End Date | 2018-12-26 |
| Marketing Category | ANDA |
| Application Number | ANDA065440 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-08-11 |
| Marketing End Date | 2018-12-26 |
| Marketing Category | ANDA |
| Application Number | ANDA065440 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-08-11 |
| Marketing End Date | 2019-08-31 |
| Ingredient | Strength |
|---|---|
| IDARUBICIN HYDROCHLORIDE | 1 mg/mL |
| SPL SET ID: | e6b1716d-71ea-4e2b-996d-67ec40759672 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9217 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0143-9218 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0143-9219 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0143-9306 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0143-9307 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0143-9308 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0703-4154 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0703-4155 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0703-4156 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 63323-194 | Idarubicin Hydrochloride | IDARUBICIN HYDROCHLORIDE |
| 66758-055 | Idarubicin Hydrochloride | Idarubicin Hydrochloride |
| 0013-2576 | Idamycin PFS | idarubicin hydrochloride |
| 0013-2586 | Idamycin PFS | idarubicin hydrochloride |
| 0013-2596 | Idamycin PFS | idarubicin hydrochloride |