OMNIPAQUE

Orange BookUNIISPLATC V08AB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGE Healthcare Inc.

CountryUS (United States)

ATC codeV08AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0407141509
10 BOTTLE, PLASTIC in 1 BOX (0407-1415-09) / 500 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

4419T9MX03

IOHEXOL

RxCUI 5956

Orange Book

N018956

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4419T9MX03",
    "rxcui": "5956",
    "inchikey": "NTHXOOBQLCIOLC-UHFFFAOYSA-N",
    "display_name": "IOHEXOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5088be1d-a708-1cac-e063-6394a90a2aff": {
      "match": "brand_token",
      "title": "OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]",
      "spl_version": "1",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0407-1415_61f3e388-89bf-43d6-ad51-b620fff561fb",
  "productndc": "0407-1415",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "018956",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "38.8%",
        "product_no": "001",
        "approval_date": "Dec 26, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "51.8%",
        "product_no": "002",
        "approval_date": "Dec 26, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "64.7%",
        "product_no": "003",
        "approval_date": "Dec 26, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "75.5%",
        "product_no": "004",
        "approval_date": "Dec 26, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "30.2%",
        "product_no": "005",
        "approval_date": "Nov 30, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "45.3%",
        "product_no": "006",
        "approval_date": "Jun 30, 1989"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15.1%",
        "product_no": "007",
        "approval_date": "Jun 1, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.9%",
        "product_no": "008",
        "approval_date": "Apr 17, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.6%",
        "product_no": "009",
        "approval_date": "Apr 17, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOHEXOL",
  "proprietary_name": "OMNIPAQUE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA018956",
  "marketing_category": "NDA",
  "nonproprietary_name": "Iohexol",
  "start_marketing_date": "20180427",
  "active_numerator_strength": "9"
}

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