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United States · US · US:70511-142_c727199d-f4cd-4658-8fdf-568590beface
Bivalirudin
Orange BookUNIISPLATC B01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMAIA Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeB01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170511142501 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-50) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE
- ndc11705111428410 VIAL, SINGLE-DOSE in 1 CARTON (70511-142-84) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
TN9BEX005G
BIVALIRUDIN
RxCUI 60819
Orange Book
N211215
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": "70511-142_c727199d-f4cd-4658-8fdf-568590beface",
"productndc": "70511-142",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "211215",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Jul 25, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIVALIRUDIN",
"proprietary_name": "Bivalirudin",
"active_ingred_unit": "mg/1",
"application_number": "NDA211215",
"marketing_category": "NDA",
"nonproprietary_name": "Bivalirudin",
"start_marketing_date": "20240527",
"active_numerator_strength": "250"
}Related drugs
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