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United States · US · US:70436-121_3f886711-cb41-3241-e063-6394a90a5bc7
GADOTERIDOL
Orange BookUNIISPLATC V08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSlate Run Pharmaceuticals, LLC
CountryUS (United States)
ATC codeV08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1170436121315 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSE
- ndc1170436121335 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSE
- ndc1170436121345 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34) / 15 mL in 1 VIAL, SINGLE-DOSE
- ndc1170436121355 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
0199MV609F
GADOTERIDOL
RxCUI 25483
Orange Book
A218749
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": {
"538a70e0-061c-40d2-8447-5b7a4e61a55f": {
"match": "brand_token",
"title": "GADOTERIDOL INJECTION [SLATE RUN PHARMACEUTICALS, LLC]",
"spl_version": "2",
"published_date": "2025-09-29"
}
},
"productid": "70436-121_3f886711-cb41-3241-e063-6394a90a5bc7",
"productndc": "70436-121",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "218749",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "279.3MG/ML",
"product_no": "001",
"approval_date": "Feb 11, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GADOTERIDOL",
"proprietary_name": "GADOTERIDOL",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218749",
"marketing_category": "ANDA",
"nonproprietary_name": "GADOTERIDOL",
"start_marketing_date": "20250220",
"active_numerator_strength": "279.3"
}Related drugs
Other records sharing ATC code V08CA04.
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