🇺🇸
United States · US · US:65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3
Gadobutrol
UNIISPLATC V08CA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeV08CA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1165219281025 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)
- ndc1165219281072 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)
- ndc1165219281102 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)
- ndc1165219281152 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)
Annotations
UNII (FDA Substance ID)
1BJ477IO2L
GADOBUTROL
RxCUI 84990
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": "65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3",
"productndc": "65219-281",
"dosage_form": "INJECTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GADOBUTROL",
"proprietary_name": "Gadobutrol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215061",
"marketing_category": "ANDA",
"nonproprietary_name": "Gadobutrol",
"start_marketing_date": "20230414",
"active_numerator_strength": "604.72"
}Related drugs
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Access this data programmatically
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