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United States · US · US:61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7
Genvoya
Orange BookUNIISPLATC V03AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeV03AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619581901130 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)
Annotations
UNII (FDA Substance ID)
LW2E03M5PG
COBICISTAT
RxCUI 1306284
Orange Book
N207561
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "LW2E03M5PG",
"rxcui": "1306284",
"inchikey": "ZCIGNRJZKPOIKD-CQXVEOKZSA-N",
"display_name": "COBICISTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"34784acf-15ed-4715-b504-eb30430518e9": {
"match": "brand_token",
"title": "GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]",
"spl_version": "22",
"published_date": "2025-02-05"
}
},
"productid": "61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7",
"productndc": "61958-1901",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207561",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG;150MG;200MG;EQ 10MG BASE",
"product_no": "001",
"approval_date": "Nov 5, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
"proprietary_name": "Genvoya",
"active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "NDA207561",
"marketing_category": "NDA",
"nonproprietary_name": "elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide",
"start_marketing_date": "20151105",
"active_numerator_strength": "150; 150; 200; 10"
}Related drugs
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