Visipaque

Orange BookUNIISPLATC V08AB09

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

Identification

ManufacturerGE Healthcare Inc.

CountryUS (United States)

ATC codeV08AB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0407222216
10 BOTTLE, PLASTIC in 1 BOX (0407-2222-16) / 50 mL in 1 BOTTLE, PLASTIC
ndc11
0407222217
10 BOTTLE, PLASTIC in 1 BOX (0407-2222-17) / 100 mL in 1 BOTTLE, PLASTIC
ndc11
0407222219
10 BOTTLE, PLASTIC in 1 BOX (0407-2222-19) / 150 mL in 1 BOTTLE, PLASTIC
ndc11
0407222221
10 BOTTLE, PLASTIC in 1 BOX (0407-2222-21) / 200 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

HW8W27HTXX

IODIXANOL

RxCUI 27729

Orange Book

N020351

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "HW8W27HTXX",
    "rxcui": "27729",
    "inchikey": "NBQNWMBBSKPBAY-UHFFFAOYSA-N",
    "display_name": "IODIXANOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVASCULAR",
  "spl_meta": {
    "2d964c13-88ad-43be-88d4-a3a7ea4d5b5e": {
      "match": "brand_token",
      "title": "VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]",
      "spl_version": "17",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0407-2222_3bf8b69f-3b64-4112-b08a-53bbf6dd57e8",
  "productndc": "0407-2222",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020351",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "55%",
        "product_no": "001",
        "approval_date": "Mar 22, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "65.2%",
        "product_no": "002",
        "approval_date": "Mar 22, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IODIXANOL",
  "proprietary_name": "Visipaque",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020351",
  "marketing_category": "NDA",
  "nonproprietary_name": "Iodixanol",
  "start_marketing_date": "20021213",
  "active_numerator_strength": "270"
}

Related drugs

Other records sharing ATC code V08AB09.

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