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United States · US · US:0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17
OMNISCAN
Orange BookUNIISPLATC V08CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGE Healthcare Inc.
CountryUS (United States)
ATC codeV08CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11040706901010 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL
- ndc11040706901510 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL
- ndc11040706902010 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
84F6U3J2R6
GADODIAMIDE
RxCUI 41144
Orange Book
N020123
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "84F6U3J2R6",
"rxcui": "41144",
"inchikey": "HZHFFEYYPYZMNU-UHFFFAOYSA-K",
"display_name": "GADODIAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a": {
"match": "brand_token",
"title": "OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]",
"spl_version": "24",
"published_date": "2025-04-28"
}
},
"productid": "0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17",
"productndc": "0407-0690",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "020123",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "287MG/ML",
"product_no": "001",
"approval_date": "Jan 8, 1993"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GADODIAMIDE",
"proprietary_name": "OMNISCAN",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020123",
"marketing_category": "NDA",
"nonproprietary_name": "gadodiamide",
"start_marketing_date": "20020419",
"active_numerator_strength": "287"
}Related drugs
Other records sharing ATC code V08CA03.
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