Mitoxantrone 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 Mitoxantrone Hydrochloride.
| Product ID | 63323-132_9b009bb2-02c2-d844-e053-2a95a90a242c |
| NDC | 63323-132 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Mitoxantrone |
| Generic Name | Mitoxantrone Hydrochloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2006-04-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077496 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | MITOXANTRONE HYDROCHLORIDE |
| Active Ingredient Strength | 2 mg/mL |
| Pharm Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2006-04-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077496 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-04-11 |
| Marketing Category | ANDA |
| Application Number | ANDA077496 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-04-11 |
| Marketing Category | ANDA |
| Application Number | ANDA077496 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-04-11 |
| Ingredient | Strength |
|---|---|
| MITOXANTRONE HYDROCHLORIDE | 2 mg/mL |
| SPL SET ID: | fcb8ef8a-f770-4416-8fc5-fa01d98c8eee |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0703-4680 | mitoXANTRONE | mitoXANTRONE |
| 0703-4685 | mitoXANTRONE | mitoXANTRONE |
| 0703-4686 | mitoXANTRONE | mitoXANTRONE |
| 61703-343 | Mitoxantrone | Mitoxantrone |
| 63323-132 | Mitoxantrone | MITOXANTRONE HYDROCHLORIDE |