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United States · US · US:55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0

Argatroban

Orange BookUNIISPLATC B01AE03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeB01AE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5515024101
    1 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-01) / 50 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    5515024110
    10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
IY90U61Z3S
ARGATROBAN
RxCUI 15202
Orange Book
N209552
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "IY90U61Z3S",
    "rxcui": "15202",
    "inchikey": "AIEZTKLTLCMZIA-CZSXTPSTSA-N",
    "display_name": "ARGATROBAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b0dedf95-8395-46bf-b94a-dcf2dd085942": {
      "match": "brand_token",
      "title": "ARGATROBAN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "6",
      "published_date": "2026-05-25"
    }
  },
  "productid": "55150-241_22fd3221-0cbe-4fc2-b4ca-e93faa99b8c0",
  "productndc": "55150-241",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209552",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG/50ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 27, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARGATROBAN",
  "proprietary_name": "Argatroban",
  "active_ingred_unit": "mg/50mL",
  "application_number": "NDA209552",
  "marketing_category": "NDA",
  "nonproprietary_name": "Argatroban",
  "start_marketing_date": "20181127",
  "active_numerator_strength": "50"
}

Related drugs

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