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 · 11

ndc11
5041934405
10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASS
ndc11
5041934410
10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASS
ndc11
5041934412
10 VIAL, GLASS in 1 CARTON (50419-344-12) / 125 mL in 1 VIAL, GLASS
ndc11
5041934415
10 VIAL, GLASS in 1 CARTON (50419-344-15) / 150 mL in 1 VIAL, GLASS
ndc11
5041934421
10 BOTTLE in 1 PACKAGE (50419-344-21) / 200 mL in 1 BOTTLE
ndc11
5041934423
10 BOTTLE in 1 PACKAGE (50419-344-23) / 200 mL in 1 BOTTLE
ndc11
5041934432
8 BOTTLE in 1 PACKAGE (50419-344-32) / 500 mL in 1 BOTTLE
ndc11
5041934458
8 BOTTLE in 1 PACKAGE (50419-344-58) / 500 mL in 1 BOTTLE
ndc11
5041934465
8 BOTTLE in 1 PACKAGE (50419-344-65) / 500 mL in 1 BOTTLE
ndc11
5041934491
10 VIAL, GLASS in 1 CARTON (50419-344-91) / 100 mL in 1 VIAL, GLASS
ndc11
5041934497
8 BOTTLE in 1 PACKAGE (50419-344-97) / 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": "50419-344_4314fa34-edbc-44f3-b40b-277c6fbd2ab0",
  "productndc": "50419-344",
  "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": "300"
}

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