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United States · US · US:0270-1111_ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2
ProHance
Orange BookUNIISPLATC V08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBracco Diagnostics Inc
CountryUS (United States)
ATC codeV08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1102701111705 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
- ndc1102701111855 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
Annotations
UNII (FDA Substance ID)
0199MV609F
GADOTERIDOL
RxCUI 25483
Orange Book
N021489
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0199MV609F",
"rxcui": "25483",
"inchikey": "DPNNNPAKRZOSMO-UHFFFAOYSA-K",
"display_name": "GADOTERIDOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"778aee03-7d4c-481a-be8a-a75db0702f5a": {
"match": "brand_token",
"title": "PROHANCE (GADOTERIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]",
"spl_version": "24",
"published_date": "2025-03-21"
}
},
"productid": "0270-1111_ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2",
"productndc": "0270-1111",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021489",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "279.3MG/ML",
"product_no": "001",
"approval_date": "Oct 9, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GADOTERIDOL",
"proprietary_name": "ProHance",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021489",
"marketing_category": "NDA",
"nonproprietary_name": "gadoteridol",
"start_marketing_date": "20031009",
"active_numerator_strength": "279.3"
}Related drugs
Other records sharing ATC code V08CA04.
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