iopamidol

Orange BookUNIISPLATC V08AB04

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

Identification

ManufacturerSlate Run Pharmaceuticals, LLC

CountryUS (United States)

ATC codeV08AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7043621180
1 VIAL, SINGLE-DOSE in 1 CARTON (70436-211-80) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-211-37)

Annotations

UNII (FDA Substance ID)

JR13W81H44

IOPAMIDOL

RxCUI 5966

Orange Book

A217134

AP2APAPAP

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": {
    "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": "70436-211_3a1c5a58-814e-8d80-e063-6394a90ac71d",
  "productndc": "70436-211",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "41%",
        "product_no": "001",
        "approval_date": "Sep 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "51%",
        "product_no": "002",
        "approval_date": "Apr 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "61%",
        "product_no": "003",
        "approval_date": "Apr 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "76%",
        "product_no": "004",
        "approval_date": "Apr 9, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOPAMIDOL",
  "proprietary_name": "iopamidol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "iopamidol",
  "start_marketing_date": "20240415",
  "active_numerator_strength": "408"
}

Related drugs

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