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United States · US · US:50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2

EOVIST

Orange BookUNIISPLATC V08CA10

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

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeV08CA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5041932005
    5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    5041932015
    5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    5041932075
    5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
HOY74VZE0M
GADOXETATE DISODIUM
RxCUI 637320
Orange Book
N022090
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "HOY74VZE0M",
    "rxcui": "637320",
    "inchikey": "SLYTULCOCGSBBJ-FCQHKQNSSA-I",
    "display_name": "GADOXETATE DISODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "6218b1e1-cbc3-4c14-bec7-528ac163a561": {
      "match": "brand_token",
      "title": "EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "25",
      "published_date": "2026-03-04"
    }
  },
  "productid": "50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2",
  "productndc": "50419-320",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022090",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.8143GM/10ML (181.43MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 3, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.72145GM/15ML (181.43MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 4, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOXETATE DISODIUM",
  "proprietary_name": "EOVIST",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022090",
  "marketing_category": "NDA",
  "nonproprietary_name": "Gadoxetate Disodium",
  "start_marketing_date": "20080703",
  "active_numerator_strength": "181.43"
}

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