DOTAREM

In shortageOrange BookUNIISPLATC V08CA02

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

Identification

ManufacturerGuerbet LLC

CountryUS (United States)

ATC codeV08CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6768420000
10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL
ndc11
6768420001
10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL
ndc11
6768420002
10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL
ndc11
6768420003
10 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

L0ND3981AG

GADOTERATE MEGLUMINE

RxCUI 1421151

Orange Book

N204781

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": {
    "82b83e61-6af8-4225-aa39-8cbf206f65b0": {
      "match": "brand_token",
      "title": "DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC]",
      "spl_version": "17",
      "published_date": "2025-03-21"
    }
  },
  "productid": "67684-2000_313093fe-89fb-4ca8-973c-f36175bb47df",
  "productndc": "67684-2000",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204781",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "37.69GM/100ML (376.9MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 20, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "3.769GM/10ML (376.9MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 20, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5.6535GM/15ML (376.9MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 20, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "7.538GM/20ML (376.9MG/ML)",
        "product_no": "004",
        "approval_date": "Mar 20, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1.8845GM/5ML (376.9MG/ML)",
        "product_no": "005",
        "approval_date": "Mar 31, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOTERATE MEGLUMINE",
  "shortage_reason": "Gadoterate Meglumine Injection",
  "shortage_status": "current",
  "proprietary_name": "DOTAREM",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA204781",
  "marketing_category": "NDA",
  "nonproprietary_name": "gadoterate meglumine",
  "start_marketing_date": "20130320",
  "active_numerator_strength": "376.9"
}

Related drugs

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