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United States · US · US:16729-275_1fbdba30-8018-d7d3-e063-6294a90ae6b6
Bivalirudin
Orange BookUNIISPLATC B01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare, Inc.
CountryUS (United States)
ATC codeB01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11167292756710 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03)
Annotations
UNII (FDA Substance ID)
TN9BEX005G
BIVALIRUDIN
RxCUI 60819
Orange Book
A206551
AP
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": "16729-275_1fbdba30-8018-d7d3-e063-6294a90ae6b6",
"productndc": "16729-275",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "206551",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/VIAL",
"product_no": "001",
"approval_date": "Nov 22, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIVALIRUDIN",
"proprietary_name": "Bivalirudin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA206551",
"marketing_category": "ANDA",
"nonproprietary_name": "bivalirudin",
"start_marketing_date": "20181107",
"active_numerator_strength": "250"
}Related drugs
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- GBAngiox 250mg powder for concentrate for solution for infusion vialsThe Medicines Company UK Ltd
- 🇺🇸bivalirudinCivica, Inc.
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