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United States · US · US:63323-132_0b47411d-1c42-4241-9301-4ecc3197470c
Mitoxantrone
Orange BookUNIISPLATC L01DB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01DB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1163323132101 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) / 10 mL in 1 VIAL, MULTI-DOSE
- ndc1163323132121 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) / 12.5 mL in 1 VIAL, MULTI-DOSE
- ndc1163323132151 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 15 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
U6USW86RD0
MITOXANTRONE HYDROCHLORIDE
RxCUI 203129
Orange Book
A077496
APAPAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U6USW86RD0",
"rxcui": "203129",
"inchikey": "ZAHQPTJLOCWVPG-UHFFFAOYSA-N",
"display_name": "MITOXANTRONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"accf9569-4b57-4e83-a7db-4e890a75d1ba": {
"match": "brand_token",
"title": "MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]",
"spl_version": "25",
"published_date": "2025-07-17"
}
},
"productid": "63323-132_0b47411d-1c42-4241-9301-4ecc3197470c",
"productndc": "63323-132",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "077496",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 20MG BASE/10ML (EQ 2MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 11, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)",
"product_no": "002",
"approval_date": "Apr 11, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 30MG BASE/15ML (EQ 2MG BASE/ML)",
"product_no": "003",
"approval_date": "Apr 11, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MITOXANTRONE HYDROCHLORIDE",
"proprietary_name": "Mitoxantrone",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077496",
"marketing_category": "ANDA",
"nonproprietary_name": "MITOXANTRONE HYDROCHLORIDE",
"start_marketing_date": "20060411",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01DB07.
- DKMitoxantron "Ebewe"Ebewe Pharma Ges.m.b.H. Nfg. KG
- FIMitoxantron AccordAccord Healthcare B.V.
- NLMitoxantron Accord 2 mg/ml, concentraat voor oplossing voor infusieAccord Healthcare B.V.
- FIMitoxantron EbeweEbewe Pharma Ges.m.b.H. Nfg.KG
- NOMitoxantron EbeweEBEWE Pharma Ges.m.b.H Nfg. KG
- FIMitoxantron EbeweParanova Oy
- PLMitoxantron SandozSandoz GmbH
- NLMitoxantron Sandoz 2 mg/ml, concentraat voor oplossing voor infusieSandoz B.V.
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