Drug Database
Back to search

United States· US:59676-702_415acee9-3121-56fb-e063-6394a90a9d83

SIRTURO

A bedaquiline product containing bedaquiline fumarate, registered in United States by Janssen Products, LP. The same ATC class is registered in 13 of our 19 countries.

ATC J04AK05US 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…normalisedSIRTUROATCJ04AK05REGISTER NO.US:59676-702_415acee9…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about bedaquiline fumarateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Bedaquiline is registered in 13 of 19 countries.

Countries holding a registration under ATC J04AK05 (bedaquiline), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 8 of them publish a price we can compare per daily dose
Search bedaquiline products by name

Bedaquiline · ATC J04AK05

13 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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
BEDAQUILINE FUMARATE
Manufacturer
Janssen Products, LP
Country
United States (US)
ATC code
J04AK05
ATC class
Bedaquiline
Defined daily dose
86 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    5967670260
    60 TABLET in 1 BOTTLE (59676-702-60)
  • ndc11
    59676-702-60

Regulatory notes

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

Interactions

325 interactions on record for bedaquiline.

Graded by severity as the source publishes them — 141 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
Check bedaquiline against other medicinesHow interaction checks work

Bedaquiline · interactions on record

325 records

  • 141 severe
  • 182 moderate
  • 2 minor

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • OndansetronA04AA01severe
  • GranisetronA04AA02severe
  • 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

Bedaquiline in 12 other countries

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

All bedaquiline products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Sirturo
  • Liechtenstein · Sirturo
  • Norway · Sirturo

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/5b38b3f4-e9ca-4e27-b487-48f5f36dec4c
GET /v1/drugs/5b38b3f4-e9ca-4e27-b487-48f5f36dec4c?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": "ORAL",
  "source": "ndc",
  "strength": "20",
  "substance": "BEDAQUILINE FUMARATE",
  "productndc": "59676-702",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA204384",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about bedaquiline.

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