CLARISCAN

In shortageOrange BookUNIISPLATC V08CA02

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

Identification

ManufacturerGE Healthcare

CountryUS (United States)

ATC codeV08CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0407294370
10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) / 100 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

L0ND3981AG

GADOTERATE MEGLUMINE

RxCUI 1421151

Orange Book

A210016

APAPAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Gadoterate Meglumine Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "L0ND3981AG",
    "rxcui": "1421151",
    "inchikey": "RYHQMKVRYNEBNJ-BMWGJIJESA-K",
    "display_name": "GADOTERATE MEGLUMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "6f8c9fac-c995-4bf4-950d-ab89deb291b5": {
      "match": "brand_token",
      "title": "CLARISCAN (GADOTERATE MEGLUMINE) INJECTION, SOLUTION [GE HEALTHCARE]",
      "spl_version": "16",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0407-2943_03f42c78-1d36-46fd-b570-042571e5912e",
  "productndc": "0407-2943",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210016",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "3.769GM/10ML (376.9MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5.6535GM/15ML (376.9MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "7.538GM/20ML (376.9MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "37.69GM/100ML (376.9MG/ML)",
        "product_no": "004",
        "approval_date": "Aug 4, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.8845GM/5ML (376.9MG/ML)",
        "product_no": "005",
        "approval_date": "Nov 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOTERATE MEGLUMINE",
  "shortage_reason": "Gadoterate Meglumine Injection",
  "shortage_status": "current",
  "proprietary_name": "CLARISCAN",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210016",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gadoterate meglumine",
  "start_marketing_date": "20191101",
  "active_numerator_strength": "376.9"
}

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