Gadoterate Meglumine

In shortageUNIISPLATC V08CA02

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeV08CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521908850
6 CARTON in 1 BOX (65219-088-50) / 1 VIAL in 1 CARTON (65219-088-06) / 100 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

L0ND3981AG

GADOTERATE MEGLUMINE

RxCUI 1421151

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": {
    "fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709": {
      "match": "brand_token",
      "title": "GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "2",
      "published_date": "2025-11-27"
    }
  },
  "productid": "65219-088_8b9a98ef-bee6-43fc-a39d-2e5a3c226653",
  "productndc": "65219-088",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOTERATE MEGLUMINE",
  "shortage_reason": "Gadoterate Meglumine Injection",
  "shortage_status": "current",
  "proprietary_name": "Gadoterate Meglumine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215982",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gadoterate meglumine",
  "start_marketing_date": "20220620",
  "active_numerator_strength": "376.9"
}

Related drugs

Other records sharing ATC code V08CA02.

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