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United States · US · US:71288-427_2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7
BIVALIRUDIN
Orange BookUNIISPLATC B01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11712884271110 VIAL, SINGLE-DOSE in 1 CARTON (71288-427-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-427-10)
Annotations
UNII (FDA Substance ID)
TN9BEX005G
BIVALIRUDIN
RxCUI 60819
Orange Book
A091602
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": "71288-427_2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7",
"productndc": "71288-427",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "091602",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/VIAL",
"product_no": "001",
"approval_date": "Jul 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIVALIRUDIN",
"proprietary_name": "BIVALIRUDIN",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA091602",
"marketing_category": "ANDA",
"nonproprietary_name": "BIVALIRUDIN",
"start_marketing_date": "20180716",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code B01AE06.
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- 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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