ISOVUE-M

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 · 1

ndc11
0270141111
10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-11) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

JR13W81H44

IOPAMIDOL

RxCUI 5966

Orange Book

N018735

AP1APAPAPAP2AP

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": "INTRATHECAL",
  "spl_meta": {
    "11e893d2-0183-4581-b908-c8b7302c7edb": {
      "match": "brand_token",
      "title": "ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]",
      "spl_version": "10",
      "published_date": "2026-02-13"
    }
  },
  "productid": "0270-1411_07cc86aa-255e-f459-c9c5-747f57811163",
  "productndc": "0270-1411",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018735",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP1",
        "strength": "41%",
        "product_no": "001",
        "approval_date": "Dec 31, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "61%",
        "product_no": "002",
        "approval_date": "Dec 31, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "76%",
        "product_no": "003",
        "approval_date": "Dec 31, 1985"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "61%",
        "product_no": "004",
        "approval_date": "Dec 31, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "26%",
        "product_no": "005",
        "approval_date": "Oct 21, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "41%",
        "product_no": "006",
        "approval_date": "Jul 7, 1987"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "51%",
        "product_no": "007",
        "approval_date": "Jul 6, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOPAMIDOL",
  "proprietary_name": "ISOVUE-M",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA018735",
  "marketing_category": "NDA",
  "nonproprietary_name": "IOPAMIDOL",
  "start_marketing_date": "19851231",
  "active_numerator_strength": "408"
}

Related drugs

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