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United States · US · US:61958-2505_245103e5-132e-4695-9b7d-bda2f2830ec3
Biktarvy
Orange BookUNIISPLATC J05AR
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AR
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11619582505130 TABLET in 1 BOTTLE, PLASTIC (61958-2505-1)
Annotations
UNII (FDA Substance ID)
4L5MP1Y7W7
BICTEGRAVIR SODIUM
RxCUI 1999661
Orange Book
N210251
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4L5MP1Y7W7",
"rxcui": "1999661",
"inchikey": "WJNFBIVCQMPPJC-FQYDJHLKSA-M",
"display_name": "BICTEGRAVIR SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"664cb8f0-1f65-441b-b0d9-ba3d798be309": {
"match": "brand_token",
"title": "BIKTARVY (BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]",
"spl_version": "24",
"published_date": "2026-04-13"
}
},
"productid": "61958-2505_245103e5-132e-4695-9b7d-bda2f2830ec3",
"productndc": "61958-2505",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210251",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE;200MG;EQ 25MG BASE",
"product_no": "001",
"approval_date": "Feb 7, 2018"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 30MG BASE;120MG;EQ 15MG BASE",
"product_no": "002",
"approval_date": "Oct 7, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
"proprietary_name": "Biktarvy",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA210251",
"marketing_category": "NDA",
"nonproprietary_name": "bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate",
"start_marketing_date": "20211007",
"active_numerator_strength": "30; 120; 15"
}Related drugs
Other records sharing ATC code J05AR.
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