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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

  • ndc11
    7299010310
    10 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"
}

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