🇺🇸
United States · US · US:55150-210_eb82831b-a234-4818-bbf2-e75e45647b77
BIVALIRUDIN
Orange BookUNIISPLATC B01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeB01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11551502101010 VIAL, SINGLE-DOSE in 1 CARTON (55150-210-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
TN9BEX005G
BIVALIRUDIN
RxCUI 60819
Orange Book
A205962
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TN9BEX005G",
"rxcui": "60819",
"inchikey": null,
"display_name": "BIVALIRUDIN",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"19a4afc5-151d-4d3c-bfef-48aa8797d695": {
"match": "brand_token",
"title": "BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]",
"spl_version": "2",
"published_date": "2025-09-15"
}
},
"productid": "55150-210_eb82831b-a234-4818-bbf2-e75e45647b77",
"productndc": "55150-210",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "205962",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "250MG/VIAL",
"product_no": "001",
"approval_date": "Jul 27, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIVALIRUDIN",
"proprietary_name": "BIVALIRUDIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205962",
"marketing_category": "ANDA",
"nonproprietary_name": "BIVALIRUDIN",
"start_marketing_date": "20180727",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code B01AE06.
- CAANGIOMAXSANDOZ CANADA INCORPORATED
- FIAngioxThe Medicines Company UK Ltd
- FIAngioxOrifarm Oy
- BEAngiox 250 mgThe Medicines Company
- GBAngiox 250mg powder for concentrate for solution for infusion vialsThe Medicines Company UK Ltd
- 🇺🇸bivalirudinCivica, Inc.
- 🇺🇸bivalirudinSlate Run Pharmaceuticals, LLC
- 🇺🇸BivalirudinMAIA Pharmaceuticals, Inc.
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