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United States · US · US:50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2
EOVIST
Orange BookUNIISPLATC V08CA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeV08CA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1150419320055 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE
- ndc1150419320155 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE
- ndc1150419320755 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
HOY74VZE0M
GADOXETATE DISODIUM
RxCUI 637320
Orange Book
N022090
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HOY74VZE0M",
"rxcui": "637320",
"inchikey": "SLYTULCOCGSBBJ-FCQHKQNSSA-I",
"display_name": "GADOXETATE DISODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"6218b1e1-cbc3-4c14-bec7-528ac163a561": {
"match": "brand_token",
"title": "EOVIST (GADOXETATE DISODIUM) INJECTION, SOLUTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "25",
"published_date": "2026-03-04"
}
},
"productid": "50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2",
"productndc": "50419-320",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "022090",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.8143GM/10ML (181.43MG/ML)",
"product_no": "001",
"approval_date": "Jul 3, 2008"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "2.72145GM/15ML (181.43MG/ML)",
"product_no": "002",
"approval_date": "Feb 4, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GADOXETATE DISODIUM",
"proprietary_name": "EOVIST",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022090",
"marketing_category": "NDA",
"nonproprietary_name": "Gadoxetate Disodium",
"start_marketing_date": "20080703",
"active_numerator_strength": "181.43"
}Related drugs
Other records sharing ATC code V08CA10.
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