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
7133422011
1 BLISTER PACK in 1 CARTON (71334-220-11) / 7 TABLET, FILM COATED in 1 BLISTER PACK

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": "71334-220_bdb78a70-8e28-47d7-a211-f8841fa17d22",
  "productndc": "71334-220",
  "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": "5"
}

Related drugs

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