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United States · US · US:50633-340_445e0469-117b-0ed5-e063-6394a90abe40
AURLUMYN
Orange BookUNIISPLATC B01AC11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBTG International Inc
CountryUS (United States)
ATC codeB01AC11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150633340011 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
JED5K35YGL
ILOPROST
RxCUI 40138
Orange Book
N217933
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "JED5K35YGL",
"rxcui": "40138",
"inchikey": "HIFJCPQKFCZDDL-ACWOEMLNSA-N",
"display_name": "ILOPROST",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"34036fc0-6832-d066-e063-6394a90a18a4": {
"match": "brand_token",
"title": "AURLUMYN (ILOPROST) INJECTION, SOLUTION [BTG INTERNATIONAL INC]",
"spl_version": "3",
"published_date": "2025-11-27"
}
},
"productid": "50633-340_445e0469-117b-0ed5-e063-6394a90abe40",
"productndc": "50633-340",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217933",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MCG/ML (100MCG/ML)",
"product_no": "001",
"approval_date": "Feb 13, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ILOPROST",
"proprietary_name": "AURLUMYN",
"active_ingred_unit": "ug/mL",
"application_number": "NDA217933",
"marketing_category": "NDA",
"nonproprietary_name": "ILOPROST",
"start_marketing_date": "20250801",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code B01AC11.
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