🇺🇸
United States · US · US:72990-103_7691bd08-693e-4662-b095-6f19f154c2ae
DEFENCATH
Orange BookUNIISPLATC B01AB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCorMedix Inc.
CountryUS (United States)
ATC codeB01AB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11729901031010 VIAL, SINGLE-DOSE in 1 CARTON (72990-103-10) / 3 mL in 1 VIAL, SINGLE-DOSE (72990-103-03)
Annotations
UNII (FDA Substance ID)
T2410KM04A
HEPARIN
RxCUI 5224
Orange Book
N214520
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "T2410KM04A",
"rxcui": "5224",
"inchikey": null,
"display_name": "HEPARIN",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRALUMINAL",
"spl_meta": {
"13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6": {
"match": "brand_token",
"title": "DEFENCATH (TAUROLIDINE AND HEPARIN) SOLUTION [CORMEDIX INC.]",
"spl_version": "7",
"published_date": "2025-11-17"
}
},
"productid": "72990-103_7691bd08-693e-4662-b095-6f19f154c2ae",
"productndc": "72990-103",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "214520",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)",
"product_no": "001",
"approval_date": "Nov 15, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)",
"product_no": "002",
"approval_date": "Nov 15, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HEPARIN; TAUROLIDINE",
"proprietary_name": "DEFENCATH",
"active_ingred_unit": "[USP'U]/3mL; mg/3mL",
"application_number": "NDA214520",
"marketing_category": "NDA",
"nonproprietary_name": "taurolidine and heparin",
"start_marketing_date": "20240409",
"active_numerator_strength": "3000; 40.5"
}Related drugs
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