Gadobutrol

Orange BookUNIISPLATC V08CA09

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeV08CA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521928965
10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10)

Annotations

UNII (FDA Substance ID)

1BJ477IO2L

GADOBUTROL

RxCUI 84990

Orange Book

A216081

APAPAPAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1BJ477IO2L",
    "rxcui": "84990",
    "inchikey": "ZPDFIIGFYAHNSK-CTHHTMFSSA-K;ZPDFIIGFYAHNSK-YYLIZZNMSA-K",
    "display_name": "GADOBUTROL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c0dd1618-0bb3-4974-846b-e5afc2311ae6": {
      "match": "brand_token",
      "title": "GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "4",
      "published_date": "2025-11-19"
    }
  },
  "productid": "65219-289_d546f4fe-ebb3-47cf-9222-563d15caa8b1",
  "productndc": "65219-289",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216081",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "18.1416GM/30ML (604.72MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "39.3068GM/65ML (604.72MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.20944GM/2ML (604.72MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4.5354GM/7.5ML (604.72MG/ML)",
        "product_no": "004",
        "approval_date": "Nov 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "6.0472GM/10ML (604.72MG/ML)",
        "product_no": "005",
        "approval_date": "Nov 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "9.0708GM/15ML (604.72MG/ML)",
        "product_no": "006",
        "approval_date": "Nov 17, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOBUTROL",
  "proprietary_name": "Gadobutrol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216081",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gadobutrol",
  "start_marketing_date": "20231001",
  "active_numerator_strength": "604.72"
}

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