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United States · US · US:72572-035_53431803-dc0b-42dc-8766-e17c3dbdf4ea
bivalirudin
Orange BookUNIISPLATC B01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCivica, Inc.
CountryUS (United States)
ATC codeB01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11725720351010 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)
Annotations
UNII (FDA Substance ID)
TN9BEX005G
BIVALIRUDIN
RxCUI 60819
Orange Book
N020873
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": "72572-035_53431803-dc0b-42dc-8766-e17c3dbdf4ea",
"productndc": "72572-035",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "020873",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "250MG/VIAL",
"product_no": "001",
"approval_date": "Dec 15, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIVALIRUDIN",
"proprietary_name": "bivalirudin",
"active_ingred_unit": "mg/1",
"application_number": "NDA020873",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "bivalirudin",
"start_marketing_date": "20201221",
"active_numerator_strength": "250"
}Related drugs
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