🇺🇸
United States · US · US:49702-242_155cffa3-1699-44ce-bed2-b1759c1fcf66
Juluca
Orange BookUNIISPLATC J05AJ
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AJ
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11497022421330 TABLET, FILM COATED in 1 BOTTLE (49702-242-13)
Annotations
UNII (FDA Substance ID)
1Q1V9V5WYQ
DOLUTEGRAVIR SODIUM
RxCUI 1433867
Orange Book
N210192
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1Q1V9V5WYQ",
"rxcui": "1433867",
"inchikey": "UGWJRRXTMKRYNK-VSLILLSYSA-M",
"display_name": "DOLUTEGRAVIR SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"806653d1-bf35-4924-b999-ad5d21821cc1": {
"match": "brand_token",
"title": "JULUCA (DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]",
"spl_version": "15",
"published_date": "2025-11-17"
}
},
"productid": "49702-242_155cffa3-1699-44ce-bed2-b1759c1fcf66",
"productndc": "49702-242",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210192",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE;EQ 25MG BASE",
"product_no": "001",
"approval_date": "Nov 21, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE",
"proprietary_name": "Juluca",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA210192",
"marketing_category": "NDA",
"nonproprietary_name": "dolutegravir sodium and rilpivirine hydrochloride",
"start_marketing_date": "20171121",
"active_numerator_strength": "50; 25"
}Related drugs
Other records sharing ATC code J05AJ.
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- 🇫🇷DOVATO 50 mg/300 mg, comprimé pelliculéVIIV HEALTHCARE (PAYS-BAS)
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- GBGenvoya 90mg/90mg/120mg/6mg tabletsGilead Sciences Ltd
- 🇪🇸ISENTRESS 100 MG COMPRIMIDOS MASTICABLESMerck Sharp & Dohme B.V.
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