🇺🇸
United States · US · US:71288-178_37d2fbfc-59e6-437f-90d2-cab7b7d099f1
mitoXANTRONE
Orange BookUNIISPLATC L01DB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01DB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288178101 VIAL, MULTI-DOSE in 1 CARTON (71288-178-10) / 10 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
U6USW86RD0
MITOXANTRONE HYDROCHLORIDE
RxCUI 203129
Orange Book
A077356
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": "71288-178_37d2fbfc-59e6-437f-90d2-cab7b7d099f1",
"productndc": "71288-178",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "077356",
"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": "ANDA077356",
"marketing_category": "ANDA",
"nonproprietary_name": "mitoXANTRONE",
"start_marketing_date": "20250601",
"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.
Access this data programmatically
Query mitoXANTRONE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.