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United States · US · US:0270-7018_50c571d8-759c-b711-b696-41c07a6ad82a

IOMERVU

Orange BookUNIISPLATC V08AB10

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

Identification

ManufacturerBRACCO DIAGNOSTICS INC
CountryUS (United States)
ATC codeV08AB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0270701827
    10 BOTTLE, GLASS in 1 CASE (0270-7018-27) / 100 mL in 1 BOTTLE, GLASS
  • ndc11
    0270701829
    10 BOTTLE, GLASS in 1 CASE (0270-7018-29) / 200 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
17E17JBP8L
IOMEPROL
RxCUI 2606484
Orange Book
N216016
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "17E17JBP8L",
    "rxcui": "2606484",
    "inchikey": "NJKDOADNQSYQEV-UHFFFAOYSA-N",
    "display_name": "IOMEPROL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTERIAL; INTRAVENOUS",
  "spl_meta": {
    "cb2e0e00-7c93-0fb4-89a5-861641662a5a": {
      "match": "brand_token",
      "title": "IOMERVU (IOMEPROL INJECTION) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "4",
      "published_date": "2026-02-09"
    }
  },
  "productid": "0270-7018_50c571d8-759c-b711-b696-41c07a6ad82a",
  "productndc": "0270-7018",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216016",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25GM IODINE/100ML (250MG IODINE/ML)",
        "product_no": "001",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15GM IODINE/50ML (300MG IODINE/ML)",
        "product_no": "002",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30GM IODINE/100ML (300MG IODINE/ML)",
        "product_no": "003",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "45GM IODINE/150ML (300MG IODINE/ML)",
        "product_no": "004",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60GM IODINE/200ML (300MG IODINE/ML)",
        "product_no": "005",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "17.5GM IODINE/50ML (350MG IODINE/ML)",
        "product_no": "006",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "35GM IODINE/100ML (350MG IODINE/ML)",
        "product_no": "007",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "52.5GM IODINE/150ML (350MG IODINE/ML",
        "product_no": "008",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "70GM IODINE/200ML (350MG IODINE/ML)",
        "product_no": "009",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20GM IODINE/50ML (400MG IODINE/ML)",
        "product_no": "010",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40GM IODINE/100ML (400MG IODINE/ML)",
        "product_no": "011",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60GM IODINE/150ML (400MG IODINE/ML)",
        "product_no": "012",
        "approval_date": "Nov 27, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80GM IODINE/200ML (400MG IODINE/ML)",
        "product_no": "013",
        "approval_date": "Nov 27, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOMEPROL",
  "proprietary_name": "IOMERVU",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA216016",
  "marketing_category": "NDA",
  "nonproprietary_name": "Iomeprol Injection",
  "start_marketing_date": "20260101",
  "active_numerator_strength": "816"
}

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