gadoterate meglumine

In shortageOrange BookUNIISPLATC V08CA02

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

Identification

ManufacturerSlate Run Pharmaceuticals, LLC

CountryUS (United States)

ATC codeV08CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7043612331
10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL
ndc11
7043612333
10 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL
ndc11
7043612334
10 VIAL in 1 CARTON (70436-123-34) / 15 mL in 1 VIAL
ndc11
7043612335
10 VIAL in 1 CARTON (70436-123-35) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

L0ND3981AG

GADOTERATE MEGLUMINE

RxCUI 1421151

Orange Book

A218073

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": {
    "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": "70436-123_32f1536f-eb01-305c-e063-6294a90a1855",
  "productndc": "70436-123",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218073",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.8845GM/5ML (376.9MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "3.769GM/10ML (376.9MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5.6535GM/15ML (376.9MG/ML)",
        "product_no": "003",
        "approval_date": "Jun 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "7.538GM/20ML (376.9MG/ML)",
        "product_no": "004",
        "approval_date": "Jun 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "37.69GM/100ML (376.9MG/ML)",
        "product_no": "005",
        "approval_date": "Jun 17, 2024"
      }
    ],
    "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": "gadoterate meglumine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218073",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gadoterate meglumine",
  "start_marketing_date": "20240628",
  "active_numerator_strength": "376.9"
}

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