United States· US:70954-136_846ff8b6-d395-4e67-98ea-9dbfd688b97e

DAPSONE

A dapsone product containing dapsone, registered in United States by ANI Pharmaceuticals, Inc.. The same ATC class is registered in 10 of our 19 countries.

ATC J04BA02US 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…normalisedDAPSONEATCJ04BA02REGISTER NO.US:70954-136_846ff8b6…PACKS LISTED4CHECKEDSeptember 27, 2026

Where it is registered

Dapsone is registered in 10 of 19 countries.

Countries holding a registration under ATC J04BA02 (dapsone), each read from that country’s own register.

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

Dapsone · ATC J04BA02

10 / 19 countries

  • Canada
  • Denmark
  • Finlandprice
  • Germany
  • 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
DAPSONE
Manufacturer
ANI Pharmaceuticals, Inc.
Country
United States (US)
ATC code
J04BA02
ATC class
Dapsone
Defined daily dose
50 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    7095413610
    30 TABLET in 1 BOTTLE (70954-136-10)
  • ndc11
    7095413620
    100 TABLET in 1 BOTTLE (70954-136-20)
  • ndc11
    70954-136-10
  • ndc11
    70954-136-20

Regulatory notes

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

Interactions

415 interactions on record for dapsone.

Graded by severity as the source publishes them — 7 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

Dapsone · interactions on record

415 records

  • 7 severe
  • 206 moderate
  • 2 minor
  • 200 info

Most severe, free to view

  • SaquinavirJ05AE01severe
  • CladribineL01BB04severe
  • Aminolevulinic acidL01XD04severe
  • CladribineL04AA40severe
  • 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

Dapsone in 8 other countries

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

All dapsone products

Authorised across Europe · EMA

The same active substance is authorised in 8 EEA countries. Names it is sold under:

  • Germany · Dapson Zentiva, Dapson-Fatol
  • Denmark · Dapson Scanpharm
  • United Kingdom (Northern Ireland) · Dapsone Macleods Pharma Uk, Dapsone Milpharm
  • Malta · Dapsone Tillomed Laboratories
  • Netherlands · Dapson Tiofarma
  • Norway · Dapson Scanpharm
  • Poland · Dusalm
  • Portugal · Sulfona Zimaia

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/fba7e13e-3961-4327-b44c-899cf928862b
GET /v1/drugs/fba7e13e-3961-4327-b44c-899cf928862b?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": "100",
  "substance": "DAPSONE",
  "productndc": "70954-136",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA206505",
  "marketing_category": "ANDA"
}

See everything about dapsone.

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.