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United States· US:71334-215_bdb78a70-8e28-47d7-a211-f8841fa17d22

PYRUKYND

A mitapivat product containing mitapivat, registered in United States by Agios Pharmaceuticals, Inc.. The same ATC class is registered in 11 of our 19 countries.

ATC B06AX04Orange 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…normalisedPYRUKYNDATCB06AX04REGISTER NO.US:71334-215_bdb78a70…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about mitapivatAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Mitapivat is registered in 11 of 19 countries.

Countries holding a registration under ATC B06AX04 (mitapivat), 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
Search mitapivat products by name

Mitapivat · ATC B06AX04

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • Spainprice
  • 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
mitapivat
Manufacturer
Agios Pharmaceuticals, Inc.
Country
United States (US)
ATC code
B06AX04
ATC class
Mitapivat
Defined daily dose
0.1 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    7133421550
    4 BLISTER PACK in 1 CARTON (71334-215-50) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-14)

Regulatory notes

UNII (FDA substance ID)
2WTV10SIKH
MITAPIVAT
RxCUI 2594468
Orange Book
N216196
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Mitapivat in 10 other countries

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

All mitapivat products

Authorised across Europe · EMA

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

  • Iceland · Pyrukynd
  • Liechtenstein · Pyrukynd
  • Norway · Pyrukynd

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/b893dbb2-3cdd-4174-b5a5-c3a86395af5d
GET /v1/drugs/b893dbb2-3cdd-4174-b5a5-c3a86395af5d?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": "2WTV10SIKH",
    "rxcui": "2594468",
    "inchikey": "XAYGBKHKBBXDAK-UHFFFAOYSA-N",
    "display_name": "MITAPIVAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": null
  },
  "spl_meta": {
    "4ccee896-e313-4c6c-9674-b4746ada0a90": {
      "match": "brand_token",
      "title": "PYRUKYND (MITAPIVAT) TABLET, FILM COATED PYRUKYND (MITAPIVAT) KIT [AGIOS PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2026-04-24"
    }
  },
  "productid": "71334-215_bdb78a70-8e28-47d7-a211-f8841fa17d22",
  "productndc": "71334-215",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216196",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Feb 17, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Feb 17, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Feb 17, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "004",
        "approval_date": "Dec 23, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MITAPIVAT",
  "proprietary_name": "PYRUKYND",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216196",
  "marketing_category": "NDA",
  "nonproprietary_name": "mitapivat",
  "start_marketing_date": "20220218",
  "active_numerator_strength": "50"
}
API referenceMCP serverPlans

See everything about mitapivat.

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.

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