🇺🇸
United States · US · US:72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9
Ledipasvir and Sofosbuvir
Orange BookUNIISPLATC J05AP
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsegua Therapeutics LLC
CountryUS (United States)
ATC codeJ05AP
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172626260112 BLISTER PACK in 1 CARTON (72626-2601-1) / 14 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
013TE6E4WV
LEDIPASVIR
RxCUI 1591922
Orange Book
N205834
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "013TE6E4WV",
"rxcui": "1591922",
"inchikey": "VRTWBAAJJOHBQU-KMWAZVGDSA-N",
"display_name": "LEDIPASVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"46f4a73b-0cd6-4902-9092-3ac79e882c1a": {
"match": "brand_token",
"title": "LEDIPASVIR AND SOFOSBUVIR TABLET, FILM COATED [ASEGUA THERAPEUTICS LLC]",
"spl_version": "8",
"published_date": "2025-01-20"
}
},
"productid": "72626-2601_bd8387fe-8338-4241-b084-aec76726f8a9",
"productndc": "72626-2601",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "205834",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "90MG;400MG",
"product_no": "001",
"approval_date": "Oct 10, 2014"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "45MG;200MG",
"product_no": "002",
"approval_date": "Aug 28, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEDIPASVIR; SOFOSBUVIR",
"proprietary_name": "Ledipasvir and Sofosbuvir",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA205834",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Ledipasvir and Sofosbuvir",
"start_marketing_date": "20190101",
"active_numerator_strength": "90; 400"
}Related drugs
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