United States· US:70710-1243_ac4bee46-e55b-46c7-a365-0cc6147f0b79

tofacitinib

A tofacitinib product containing tofacitinib, registered in United States by Zydus Pharmaceuticals USA Inc.. The same ATC class is registered in 13 of our 19 countries.

ATC L04AF01Orange BookUS 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…normalisedtofacitinibATCL04AF01REGISTER NO.US:70710-1243_ac4bee4…PACKS LISTED2CHECKEDSeptember 12, 2026

Where it is registered

Tofacitinib is registered in 13 of 19 countries.

Countries holding a registration under ATC L04AF01 (tofacitinib), each read from that country’s own register.

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

Tofacitinib · ATC L04AF01

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • 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 tofacitinib costs, country by country.

Normalised to the WHO defined daily dose (10 mg), the median price runs from $1.99 in United States to $17.31 in Switzerland — a ×8.7 gap.

  • United States: $1.99 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Tofacitinib · price per daily dose (10 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$17.31
  • US United States$1.99 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
tofacitinib
Manufacturer
Zydus Pharmaceuticals USA Inc.
Country
United States (US)
ATC code
L04AF01
ATC class
Tofacitinib
Defined daily dose
10 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    7071012436
    60 TABLET, FILM COATED in 1 BOTTLE (70710-1243-6)
  • ndc11
    7071012438
    180 TABLET, FILM COATED in 1 BOTTLE (70710-1243-8)

Regulatory notes

UNII (FDA substance ID)
O1FF4DIV0D
TOFACITINIB CITRATE
RxCUI 1358492
Orange Book
A209829
AB
DailyMed SPL labels
1 version tracked

Interactions

512 interactions on record for tofacitinib.

Graded by severity as the source publishes them — 333 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

Tofacitinib · interactions on record

512 records

  • 333 severe
  • 171 moderate
  • 8 minor

Most severe, free to view

  • PrednisoloneA07EA01severe
  • HydrocortisoneA07EA02severe
  • PrednisoneA07EA03severe
  • BetamethasoneA07EA04severe
  • 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

Tofacitinib in 14 other countries

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

All tofacitinib products

Authorised across Europe · EMA

The same active substance is authorised in 15 EEA countries. Names it is sold under:

  • Austria · Tofacitinib Devatis, Tofacitinib Stada
  • Bulgaria · Tофацитиниб Devatis
  • Denmark · Tofacitinib Accord, Tofacitinib Newbury
  • Spain · Tofacitinib Stada
  • Finland · Tofacitinib Devatis, Tofacitinib Stada
  • France · Tofacitinib Stada
  • United Kingdom (Northern Ireland) · Tofacitinib Amarox, Tofacitinib Brown & Burk Uk
  • Croatia · Tofacitinib Accord, Tofacitinib Stada
  • Iceland · Xeljanz
  • Liechtenstein · Xeljanz
  • Malta · Tofacitinib Stada
  • Netherlands · Tofacitinib Devatis, Tofacitinib Stada
  • Norway · Tofacitinib Accord, Tofacitinib Devatis
  • Portugal · Tofacitinib Bluepharma
  • Sweden · Tofacitinib Devatis, Tofacitinib Newbury

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/deb8d226-7d4f-4c59-b439-b9a18f302f5a
GET /v1/drugs/deb8d226-7d4f-4c59-b439-b9a18f302f5a?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.

{
  "unii": {
    "unii": "O1FF4DIV0D",
    "rxcui": "1358492",
    "inchikey": "SYIKUFDOYJFGBQ-YLAFAASESA-N",
    "display_name": "TOFACITINIB CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "ac0b26d5-1352-42ff-b5ea-3eb02d8508a4": {
      "match": "brand_token",
      "title": "TOFACITINIB TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]",
      "spl_version": "5",
      "published_date": "2026-05-21"
    }
  },
  "productid": "70710-1243_ac4bee46-e55b-46c7-a365-0cc6147f0b79",
  "productndc": "70710-1243",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 13, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOFACITINIB CITRATE",
  "proprietary_name": "tofacitinib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tofacitinib",
  "start_marketing_date": "20260511",
  "active_numerator_strength": "5"
}

See everything about tofacitinib.

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.