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United States · US · US:61958-1501_74c52ec6-8358-4e63-b299-64ec1ff7f434
Sovaldi
Orange BookUNIISPLATC J05AP08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AP08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619581501128 TABLET, FILM COATED in 1 BOTTLE (61958-1501-1)
Annotations
UNII (FDA Substance ID)
WJ6CA3ZU8B
SOFOSBUVIR
RxCUI 1484911
Orange Book
N204671
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WJ6CA3ZU8B",
"rxcui": "1484911",
"inchikey": "TTZHDVOVKQGIBA-IQWMDFIBSA-N",
"display_name": "SOFOSBUVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"80beab2c-396e-4a37-a4dc-40fdb62859cf": {
"match": "brand_token",
"title": "SOVALDI (SOFOSBUVIR) TABLET, FILM COATED SOVALDI (SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC.]",
"spl_version": "16",
"published_date": "2025-01-13"
}
},
"productid": "61958-1501_74c52ec6-8358-4e63-b299-64ec1ff7f434",
"productndc": "61958-1501",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204671",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "400MG",
"product_no": "001",
"approval_date": "Dec 6, 2013"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "002",
"approval_date": "Aug 28, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOFOSBUVIR",
"proprietary_name": "Sovaldi",
"active_ingred_unit": "mg/1",
"application_number": "NDA204671",
"marketing_category": "NDA",
"nonproprietary_name": "SOFOSBUVIR",
"start_marketing_date": "20131206",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J05AP08.
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