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United States· US:68982-261_5be10bd2-a785-7f3b-0d28-d066cd5f7d24

Balfaxar

A medicinal product containing coagulation factor ix human; prothrombin; coagulation factor vii human; coagulation factor x human; protein c; protein s human, registered in United States by Octapharma USA Inc.

US label

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBalfaxarATC—REGISTER NO.US:68982-261_5be10bd2…PACKS LISTED4CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about coagulation factor ix human; prothrombin; coagulation factor vii human; coagulation factor x human; protein c; protein s humanAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
COAGULATION FACTOR IX HUMAN; PROTHROMBIN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN
Manufacturer
Octapharma USA Inc
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    68982-261-01
  • ndc11
    68982-261-02
  • ndc11
    6898226101
    1 VIAL, GLASS in 1 CARTON (68982-261-01) / 20 mL in 1 VIAL, GLASS (68982-261-81)
  • ndc11
    6898226102
    1 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82)

Regulatory notes

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

Same medicine, other countries

Coagulation factor ix human; prothrombin; coagulation factor vii human; coagulation factor x human; protein c; protein s human in 3 other countries

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

All coagulation factor ix human; prothrombin; coagulation factor vii human; coagulation factor x human; protein c; protein s human products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Beriplex P/N, Cofact
  • Belgium · Cofact, Confidex
  • Bulgaria · Octaplex, Бериплекс P/N
  • Cyprus · Beriplex P/N, Octaplex
  • Czechia · Beriplex, Ocplex
  • Germany · Beriplex P/N, Cofact
  • Denmark · Confidex, Octaplex
  • Estonia · Octaplex
  • Spain · Beriplex, Cofact
  • Finland · Cofact, Confidex
  • France · Cofact, Confidex
  • United Kingdom (Northern Ireland) · Beriplex P/N, Octaplex
  • Greece · Beriplex P/N
  • Croatia · Beriplex P/N, Octaplex
  • Hungary · Beriplex P/N, Octaplex
  • Ireland · Beriplex P/N, Octaplex Coagulation Factor Ix
  • Iceland · Cofact, Octaplex
  • Italy · Cofact, Confidex
  • Lithuania · Octaplex
  • Luxembourg · Cofact, Confidex
  • Latvia · Octaplex
  • Malta · Beriplex P/N, Octaplex
  • Netherlands · Beriplex P/N, Cofact
  • Norway · Confidex, Octaplex
  • Poland · Beriplex P/N, Octaplex
  • Portugal · Beriplex, Octaplex
  • Romania · Beriplex P/N, Pronativ
  • Sweden · Confidex, Ocplex
  • Slovenia · Beriplex P/N, Octaplex
  • Slovakia · Beriplex, Octaplex

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/66edfc00-161f-45d6-8365-1828f0fde5a9
GET /v1/drugs/66edfc00-161f-45d6-8365-1828f0fde5a9?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": "25.5; 26; 16.5; 24; 22; 22",
  "substance": "COAGULATION FACTOR IX HUMAN; PROTHROMBIN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN",
  "productndc": "68982-261",
  "dosage_form": "POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "[iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL",
  "application_number": "BLA125776",
  "marketing_category": "BLA"
}
API referenceMCP serverPlans

See everything about coagulation factor ix human; prothrombin; coagulation factor vii human; coagulation factor x human; protein c; protein s human.

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.

Try it freeOpen in the console