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United States · US · US:70436-124_16308b6e-8a2e-8431-e063-6294a90a986c

iopamidol

Orange BookUNIISPLATC V08AB04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSlate Run Pharmaceuticals
CountryUS (United States)
ATC codeV08AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7043612433
    10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33)
  • ndc11
    7043612435
    20 mL in 1 VIAL, SINGLE-DOSE (70436-124-35)
  • ndc11
    7043612452
    200 mL in 1 CARTON (70436-124-52)
  • ndc11
    7043612482
    100 mL in 1 CARTON (70436-124-82)

Annotations

UNII (FDA Substance ID)
JR13W81H44
IOPAMIDOL
RxCUI 5966
Orange Book
A215382
AP1AP
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": {
    "69e9ab05-88f8-45f9-8bc1-ed33ab1385f0": {
      "match": "brand_token",
      "title": "IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]",
      "spl_version": "3",
      "published_date": "2025-07-18"
    }
  },
  "productid": "70436-124_16308b6e-8a2e-8431-e063-6294a90a986c",
  "productndc": "70436-124",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215382",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "41%",
        "product_no": "001",
        "approval_date": "Feb 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "61%",
        "product_no": "002",
        "approval_date": "Feb 27, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOPAMIDOL",
  "proprietary_name": "iopamidol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215382",
  "marketing_category": "ANDA",
  "nonproprietary_name": "iopamidol",
  "start_marketing_date": "20230720",
  "active_numerator_strength": "408"
}

Related drugs

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