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United States · US · US:51167-113_6ec7a22b-ccd3-408e-9564-bf8b8278da39
SYMDEKO
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVertex Pharmaceuticals Incorporated
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151167113011 KIT in 1 CARTON (51167-113-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
N210491
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"302ae804-37db-44fd-ac2f-3dbdeda9aa4b": {
"match": "brand_token",
"title": "SYMDEKO (TEZACAFTOR AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]",
"spl_version": "21",
"published_date": "2026-03-30"
}
},
"productid": "51167-113_6ec7a22b-ccd3-408e-9564-bf8b8278da39",
"productndc": "51167-113",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "210491",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG;150MG, 100MG",
"product_no": "001",
"approval_date": "Feb 12, 2018"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "75MG;75MG, 50MG",
"product_no": "002",
"approval_date": "Jun 21, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "SYMDEKO",
"active_ingred_unit": null,
"application_number": "NDA210491",
"marketing_category": "NDA",
"nonproprietary_name": "Tezacaftor and Ivacaftor",
"start_marketing_date": "20190621",
"active_numerator_strength": null
}Access this data programmatically
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