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United States · US · US:0270-1111_2124d0de-8f96-6f0d-6c42-7296def2661f
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 · 4
- ndc1102701111015 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE
- ndc1102701111025 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE
- ndc1102701111035 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-03) / 20 mL in 1 VIAL, SINGLE-DOSE
- ndc1102701111045 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-04) / 5 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
0199MV609F
GADOTERIDOL
RxCUI 25483
Orange Book
N020131
AP
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_2124d0de-8f96-6f0d-6c42-7296def2661f",
"productndc": "0270-1111",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "020131",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "279.3MG/ML",
"product_no": "001",
"approval_date": "Nov 16, 1992"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GADOTERIDOL",
"proprietary_name": "ProHance",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020131",
"marketing_category": "NDA",
"nonproprietary_name": "gadoteridol",
"start_marketing_date": "19921116",
"active_numerator_strength": "279.3"
}Related drugs
Other records sharing ATC code V08CA04.
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