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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

  • ndc11
    4970224213
    30 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"
}

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