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United States · US · US:61958-3401_4fcd5eac-41a1-43cd-98c5-f733d5094ff9
Yeztugo
Orange BookUNIISPLATC J05AX31
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AX31
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1161958340114 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3401-1)
Annotations
UNII (FDA Substance ID)
BDT58WJ9WE
LENACAPAVIR SODIUM
Orange Book
N220020
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BDT58WJ9WE",
"rxcui": null,
"inchikey": "SSXPGMNGIORJAQ-PZNXWHLTSA-M",
"display_name": "LENACAPAVIR SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1c241af1-ce62-4b0a-9eb7-f6b626174f01": {
"match": "brand_token",
"title": "YEZTUGO (LENACAPAVIR SODIUM) TABLET, FILM COATED YEZTUGO (LENACAPAVIR SODIUM) KIT [GILEAD SCIENCES, INC.]",
"spl_version": "4",
"published_date": "2026-02-17"
}
},
"productid": "61958-3401_4fcd5eac-41a1-43cd-98c5-f733d5094ff9",
"productndc": "61958-3401",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "220020",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 300MG BASE",
"product_no": "001",
"approval_date": "Jun 18, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LENACAPAVIR SODIUM",
"proprietary_name": "Yeztugo",
"active_ingred_unit": "mg/1",
"application_number": "NDA220020",
"marketing_category": "NDA",
"nonproprietary_name": "LENACAPAVIR SODIUM",
"start_marketing_date": "20250618",
"active_numerator_strength": "300"
}Related drugs
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- ISSunlencaGilead Sciences Ireland UC*
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- PLSunlencaGilead Sciences Ireland UC
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