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United States · US · US:68727-800_0269ad44-e351-4411-8866-d8d53e28fb74
DEFITELIO
Orange BookUNIISPLATC B01AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJazz Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeB01AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168727800012.5 mL in 1 VIAL (68727-800-01)
- ndc11687278000225 mL in 1 CARTON (68727-800-02)
Annotations
UNII (FDA Substance ID)
L7CHH2B2J0
DEFIBROTIDE SODIUM
RxCUI 1311089
Orange Book
N208114
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L7CHH2B2J0",
"rxcui": "1311089",
"inchikey": null,
"display_name": "DEFIBROTIDE SODIUM",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"2c3db989-d7ad-41ed-9ebf-698dcf6c24ec": {
"match": "brand_token",
"title": "DEFITELIO (DEFIBROTIDE SODIUM) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2025-07-04"
}
},
"productid": "68727-800_0269ad44-e351-4411-8866-d8d53e28fb74",
"productndc": "68727-800",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "208114",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG/2.5ML (80MG/ML)",
"product_no": "001",
"approval_date": "Mar 30, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEFIBROTIDE SODIUM",
"proprietary_name": "DEFITELIO",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208114",
"marketing_category": "NDA",
"nonproprietary_name": "defibrotide sodium",
"start_marketing_date": "20160330",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code B01AX01.
- NODefitelioGentium S.r.l.
- FIDefitelioGentium S.r.l.
- DKDefitelioGentium SpA
- PLDefitelioGentium S.r.l.
- ISDefitelioGentium S.r.l.
- CADEFITELIOJAZZ PHARMACEUTICALS IRELAND LIMITED
- CZDEFITELIOGentium S.r.l., Villla Guardia, Como
- GBDefitelio 200mg/2.5ml concentrate for solution for infusion vialsJazz Pharmaceuticals UK Ltd
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