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United States · US · US:71334-230_bdb78a70-8e28-47d7-a211-f8841fa17d22
PYRUKYND
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAgios Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171334230131 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07)
Annotations
Orange Book
N216196
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": 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": "71334-230_bdb78a70-8e28-47d7-a211-f8841fa17d22",
"productndc": "71334-230",
"dosage_form": "KIT",
"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": null,
"proprietary_name": "PYRUKYND",
"active_ingred_unit": null,
"application_number": "NDA216196",
"marketing_category": "NDA",
"nonproprietary_name": "mitapivat",
"start_marketing_date": "20220218",
"active_numerator_strength": null
}Access this data programmatically
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