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 · 10

ndc11
5041934605
10 VIAL, GLASS in 1 CARTON (50419-346-05) / 50 mL in 1 VIAL, GLASS
ndc11
5041934610
10 VIAL, GLASS in 1 CARTON (50419-346-10) / 100 mL in 1 VIAL, GLASS
ndc11
5041934615
10 VIAL, GLASS in 1 CARTON (50419-346-15) / 150 mL in 1 VIAL, GLASS
ndc11
5041934620
10 VIAL, GLASS in 1 CARTON (50419-346-20) / 200 mL in 1 VIAL, GLASS
ndc11
5041934626
10 BOTTLE in 1 PACKAGE (50419-346-26) / 200 mL in 1 BOTTLE (50419-346-32)
ndc11
5041934628
10 BOTTLE in 1 PACKAGE (50419-346-28) / 200 mL in 1 BOTTLE
ndc11
5041934658
8 BOTTLE in 1 PACKAGE (50419-346-58) / 500 mL in 1 BOTTLE (50419-346-33)
ndc11
5041934665
8 BOTTLE in 1 PACKAGE (50419-346-65) / 500 mL in 1 BOTTLE
ndc11
5041934691
10 VIAL, GLASS in 1 CARTON (50419-346-91) / 100 mL in 1 VIAL, GLASS
ndc11
5041934697
8 BOTTLE in 1 PACKAGE (50419-346-97) / 500 mL in 1 BOTTLE

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": "50419-346_4314fa34-edbc-44f3-b40b-277c6fbd2ab0",
  "productndc": "50419-346",
  "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": "20091230",
  "active_numerator_strength": "370"
}

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