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United States · US · US:63323-562_2f51e657-4541-4458-8020-5063efc51eb7
Bivalirudin
Orange BookUNIISPLATC B01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633235621010 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
TN9BEX005G
BIVALIRUDIN
RxCUI 60819
Orange Book
A090189
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": "63323-562_2f51e657-4541-4458-8020-5063efc51eb7",
"productndc": "63323-562",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "090189",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/VIAL",
"product_no": "001",
"approval_date": "Oct 28, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIVALIRUDIN",
"proprietary_name": "Bivalirudin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090189",
"marketing_category": "ANDA",
"nonproprietary_name": "Bivalirudin",
"start_marketing_date": "20161028",
"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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- 🇺🇸BivalirudinMAIA Pharmaceuticals, Inc.
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