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United States· US:83257-030_09c9ae75-505b-dcae-8765-3628a32e7828

AUKELSO

A denosumab product containing denosumab, registered in United States by Biocon Biologics Inc.. The same ATC class is registered in 16 of our 19 countries.

ATC M05BX04US 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…normalisedAUKELSOATCM05BX04REGISTER NO.US:83257-030_09c9ae75…PACKS LISTED2CHECKEDJuly 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about denosumabAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Denosumab is registered in 16 of 19 countries.

Countries holding a registration under ATC M05BX04 (denosumab), each read from that country’s own register.

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

Denosumab · ATC M05BX04

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • 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.

Price per daily dose

What a daily dose of denosumab costs, country by country.

Normalised to the WHO defined daily dose (0.33 mg), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Denosumab · price per daily dose (0.33 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$1.37
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DENOSUMAB
Manufacturer
Biocon Biologics Inc.
Country
United States (US)
ATC code
M05BX04
ATC class
Denosumab
Defined daily dose
0.33 mg, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 26, 2026

Packs & prices · 2

  • ndc11
    83257-030-11
  • ndc11
    8325703011
    1 VIAL, SINGLE-USE in 1 CARTON (83257-030-11) / 1.7 mL in 1 VIAL, SINGLE-USE

Regulatory notes

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

Interactions

262 interactions on record for denosumab.

Graded by severity as the source publishes them — 3 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 denosumab against other medicinesHow interaction checks work

Denosumab · interactions on record

262 records

  • 3 severe
  • 259 moderate

Most severe, free to view

  • EtelcalcetideH05BX04severe
  • CladribineL01BB04severe
  • PrednisoloneA07EA01moderate
  • HydrocortisoneA07EA02moderate
  • 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

Denosumab in 16 other countries

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

All denosumab products

Authorised across Europe · EMA

The same active substance is authorised in 4 EEA countries. Names it is sold under:

  • United Kingdom (Northern Ireland) · Enwylma, Ponlimsi
  • Iceland · Bildyos, Bilprevda
  • Liechtenstein · Bildyos, Bilprevda
  • Norway · Bildyos, Bilprevda

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/c7d6d8b7-8c1e-46ff-be6b-cc2a3bf7168e
GET /v1/drugs/c7d6d8b7-8c1e-46ff-be6b-cc2a3bf7168e?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": "SUBCUTANEOUS",
  "source": "ndc",
  "strength": "120",
  "substance": "DENOSUMAB",
  "productndc": "83257-030",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "strength_unit": "mg/1.7mL",
  "application_number": "BLA761436",
  "marketing_category": "BLA"
}
API referenceMCP serverPlans

See everything about denosumab.

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