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United States · US · US:50090-6247_a3c4a0eb-71e8-4b35-9706-240874b78ee0
Biktarvy
Orange BookUNIISPLATC J05AR
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ05AR
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500906247030 TABLET in 1 BOTTLE, PLASTIC (50090-6247-0)
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": "50090-6247_a3c4a0eb-71e8-4b35-9706-240874b78ee0",
"productndc": "50090-6247",
"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": "20180207",
"active_numerator_strength": "50; 200; 25"
}Related drugs
Other records sharing ATC code J05AR.
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