ISOVUE

Orange BookUNIISPLATC V08AB04

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

Identification

ManufacturerBracco Diagnostics Inc

CountryUS (United States)

ATC codeV08AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0270131645
10 BOTTLE in 1 BOX (0270-1316-45) / 200 mL in 1 BOTTLE
ndc11
0270131695
6 BOTTLE in 1 BOX (0270-1316-95) / 500 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

JR13W81H44

IOPAMIDOL

RxCUI 5966

Orange Book

N020327

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "JR13W81H44",
    "rxcui": "5966",
    "inchikey": "XQZXYNRDCRIARQ-LURJTMIESA-N",
    "display_name": "IOPAMIDOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVASCULAR",
  "spl_meta": {
    "797a11d7-dcd4-43ff-311b-3b48a10da2f2": {
      "match": "brand_token",
      "title": "ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "15",
      "published_date": "2026-04-20"
    }
  },
  "productid": "0270-1316_c31a9ece-7b14-abe3-6214-f4e8c482516c",
  "productndc": "0270-1316",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020327",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "41%",
        "product_no": "001",
        "approval_date": "Oct 12, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "51%",
        "product_no": "002",
        "approval_date": "Oct 12, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "61%",
        "product_no": "003",
        "approval_date": "Oct 12, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "76%",
        "product_no": "004",
        "approval_date": "Oct 12, 1994"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOPAMIDOL",
  "proprietary_name": "ISOVUE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020327",
  "marketing_category": "NDA",
  "nonproprietary_name": "IOPAMIDOL",
  "start_marketing_date": "20140620",
  "active_numerator_strength": "755"
}

Related drugs

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