🇺🇸
United States · US · US:55111-652_2c95d0ae-12a5-4981-d4cf-99e26a7f5a69
Bivalirudin
Orange BookUNIISPLATC B01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeB01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11551116523710 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)
Annotations
UNII (FDA Substance ID)
TN9BEX005G
BIVALIRUDIN
RxCUI 60819
Orange Book
A201577
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": "INTRACAVERNOUS",
"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": "55111-652_2c95d0ae-12a5-4981-d4cf-99e26a7f5a69",
"productndc": "55111-652",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "201577",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/VIAL",
"product_no": "001",
"approval_date": "May 26, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIVALIRUDIN",
"proprietary_name": "Bivalirudin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201577",
"marketing_category": "ANDA",
"nonproprietary_name": "Bivalirudin",
"start_marketing_date": "20170531",
"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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