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United States · US · US:68974-200_2299f93e-22fc-48ac-8d06-c558fc57bb0d
FILSPARI
Orange BookUNIISPLATC C09XX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTravere Therapeutics, Inc.
CountryUS (United States)
ATC codeC09XX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11689742003030 TABLET, FILM COATED in 1 BOTTLE (68974-200-30)
Annotations
UNII (FDA Substance ID)
9242RO5URM
SPARSENTAN
Orange Book
N216403
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9242RO5URM",
"rxcui": null,
"inchikey": "WRFHGDPIDHPWIQ-UHFFFAOYSA-N",
"display_name": "SPARSENTAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d7354af1-f304-f4d9-e053-2995a90ab219": {
"match": "brand_token",
"title": "FILSPARI (SPARSENTAN) TABLET, FILM COATED [TRAVERE THERAPEUTICS, INC.]",
"spl_version": "7",
"published_date": "2026-04-17"
}
},
"productid": "68974-200_2299f93e-22fc-48ac-8d06-c558fc57bb0d",
"productndc": "68974-200",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216403",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Feb 17, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "400MG",
"product_no": "002",
"approval_date": "Feb 17, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SPARSENTAN",
"proprietary_name": "FILSPARI",
"active_ingred_unit": "mg/1",
"application_number": "NDA216403",
"marketing_category": "NDA",
"nonproprietary_name": "sparsentan",
"start_marketing_date": "20230217",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code C09XX01.
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