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 · 7

ndc11
0407294301
10 VIAL, GLASS in 1 BOX (0407-2943-01) / 10 mL in 1 VIAL, GLASS
ndc11
0407294302
10 VIAL, GLASS in 1 BOX (0407-2943-02) / 15 mL in 1 VIAL, GLASS
ndc11
0407294305
10 VIAL, GLASS in 1 BOX (0407-2943-05) / 20 mL in 1 VIAL, GLASS
ndc11
0407294306
10 VIAL, GLASS in 1 BOX (0407-2943-06) / 5 mL in 1 VIAL, GLASS
ndc11
0407294312
10 SYRINGE, PLASTIC in 1 BOX (0407-2943-12) / 10 mL in 1 SYRINGE, PLASTIC
ndc11
0407294317
10 SYRINGE, PLASTIC in 1 BOX (0407-2943-17) / 15 mL in 1 SYRINGE, PLASTIC
ndc11
0407294322
10 SYRINGE, PLASTIC in 1 BOX (0407-2943-22) / 20 mL in 1 SYRINGE, 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_10209370-babb-44f2-a9db-3e82f54a54d7",
  "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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