United States· US:55150-210_5648a9e0-d7bb-4b2b-9525-73842ae281a9

BIVALIRUDIN

A bivalirudin product containing bivalirudin, registered in United States by Eugia US LLC. The same ATC class is registered in 11 of our 19 countries.

ATC B01AE06

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBIVALIRUDINATCB01AE06REGISTER NO.US:55150-210_5648a9e0…PACKS LISTED1CHECKEDSeptember 27, 2026

Where it is registered

Bivalirudin is registered in 11 of 19 countries.

Countries holding a registration under ATC B01AE06 (bivalirudin), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 5 of them publish a price we can compare per daily dose

Bivalirudin · ATC B01AE06

11 / 19 countries

  • Belgiumprice
  • Canada
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Netherlands
  • Polandprice
  • Sweden
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BIVALIRUDIN
Manufacturer
Eugia US LLC
Country
United States (US)
ATC code
B01AE06
ATC class
Bivalirudin
Defined daily dose
0.25 g, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 1

  • ndc11
    55150-210-10

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

148 interactions on record for bivalirudin.

Graded by severity as the source publishes them — 63 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Bivalirudin · interactions on record

148 records

  • 63 severe
  • 85 moderate

Most severe, free to view

  • DicoumarolB01AA01severe
  • WarfarinB01AA03severe
  • HeparinB01AB01severe
  • DalteparinB01AB04severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Bivalirudin in 10 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All bivalirudin products

Authorised across Europe · EMA

The same active substance is authorised in 14 EEA countries. Names it is sold under:

  • Austria · Bivalirudin Accord
  • Belgium · Bivalirudin Accord Healthcare, Bivalirudin Hikma
  • Germany · Bivalirudin Accord
  • Denmark · Bivalirudin Reig Jofre
  • Spain · Bivalirudina Hikma, Bivalirudina Sala
  • Finland · Bivalirudin Bioglan
  • France · Bivalirudine Accord, Bivalirudine Hikma
  • United Kingdom (Northern Ireland) · Bivalirudin Accord Healthcare, Bivalirudin Kensington Pharma
  • Italy · Bivalirudina Accord, Bivalirudina Hikma
  • Netherlands · Bivalirudine Accord, Bivalirudine Hikma
  • Poland · Biwalirudyna Accord
  • Portugal · Bivalirudina Accord, Bivalirudina Hikma
  • Sweden · Bivalirudin Reig Jofre
  • Slovenia · Bivalirudin Accord

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/efcaccce-f71d-4a9c-bea2-db7bc626c9cc
GET /v1/drugs/efcaccce-f71d-4a9c-bea2-db7bc626c9cc?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "INTRAVENOUS",
  "source": "ndc",
  "strength": "250",
  "substance": "BIVALIRUDIN",
  "productndc": "55150-210",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA205962",
  "marketing_category": "ANDA"
}

See everything about bivalirudin.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.