Ultravist

Orange BookUNIISPLATC V08AB05

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

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.

CountryUS (United States)

ATC codeV08AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5041934705
50 mL in 1 VIAL, GLASS (50419-347-05)
ndc11
5041934720
200 mL in 1 VIAL, GLASS (50419-347-20)

Annotations

UNII (FDA Substance ID)

712BAC33MZ

IOPROMIDE

RxCUI 27781

Orange Book

N020220

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "712BAC33MZ",
    "rxcui": "27781",
    "inchikey": "DGAIEPBNLOQYER-UHFFFAOYSA-N",
    "display_name": "IOPROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTERIAL; INTRAVENOUS",
  "spl_meta": {
    "df917c3a-59a2-4ed1-8470-8a5394c73325": {
      "match": "brand_token",
      "title": "ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "25",
      "published_date": "2026-03-04"
    }
  },
  "productid": "50419-347_4314fa34-edbc-44f3-b40b-277c6fbd2ab0",
  "productndc": "50419-347",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020220",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "76.9%",
        "product_no": "001",
        "approval_date": "May 10, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "62.3%",
        "product_no": "002",
        "approval_date": "May 10, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "49.9%",
        "product_no": "003",
        "approval_date": "May 10, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "31.2%",
        "product_no": "004",
        "approval_date": "May 10, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "62.3%",
        "product_no": "005",
        "approval_date": "Nov 18, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOPROMIDE",
  "proprietary_name": "Ultravist",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020220",
  "marketing_category": "NDA",
  "nonproprietary_name": "iopromide",
  "start_marketing_date": "20220608",
  "active_numerator_strength": "300"
}

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