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United States · US · US:0270-0083_c9c87a8e-a0ca-2d0b-b547-b901932928c8
Choletec
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBracco Diagnostics Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11027000832010 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
7PV0B6ED98
MEBROFENIN
RxCUI 1311500
Orange Book
N018963
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7PV0B6ED98",
"rxcui": "1311500",
"inchikey": "MHPZZZZLAQGTHT-UHFFFAOYSA-N",
"display_name": "MEBROFENIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"fd085485-998d-42a3-879a-b2d96cb8aed7": {
"match": "brand_token",
"title": "CHOLETEC (MEBROFENIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC]",
"spl_version": "10",
"published_date": "2025-12-08"
}
},
"productid": "0270-0083_c9c87a8e-a0ca-2d0b-b547-b901932928c8",
"productndc": "0270-0083",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "018963",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "N/A",
"product_no": "001",
"approval_date": "Jan 21, 1987"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEBROFENIN",
"proprietary_name": "Choletec",
"active_ingred_unit": "mg/1",
"application_number": "NDA018963",
"marketing_category": "NDA",
"nonproprietary_name": "Mebrofenin",
"start_marketing_date": "19870121",
"active_numerator_strength": "45"
}Access this data programmatically
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