PYRUKYND

Orange BookUNIISPLATC B06AX04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAgios Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeB06AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

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

Annotations

UNII (FDA Substance ID)

2WTV10SIKH

MITAPIVAT

RxCUI 2594468

Orange Book

N216196

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2WTV10SIKH",
    "rxcui": "2594468",
    "inchikey": "XAYGBKHKBBXDAK-UHFFFAOYSA-N",
    "display_name": "MITAPIVAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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"
}

Related drugs

Other records sharing ATC code B06AX04.

Access this data programmatically

Query PYRUKYND and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs