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United States · US · US:59676-800_a8468da1-a6e7-4a14-a108-23915ccaeee8

Symtuza

Orange BookUNIISPLATC V03AX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerJanssen Products LP
CountryUS (United States)
ATC codeV03AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5967680030
    30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)
  • ndc11
    5967680099
    30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99)

Annotations

UNII (FDA Substance ID)
LW2E03M5PG
COBICISTAT
RxCUI 1306284
Orange Book
N210455
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "LW2E03M5PG",
    "rxcui": "1306284",
    "inchikey": "ZCIGNRJZKPOIKD-CQXVEOKZSA-N",
    "display_name": "COBICISTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "85a17d00-6b7c-41ea-a6b3-5ad924820dab": {
      "match": "brand_token",
      "title": "SYMTUZA (DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS LP]",
      "spl_version": "23",
      "published_date": "2026-04-20"
    }
  },
  "productid": "59676-800_a8468da1-a6e7-4a14-a108-23915ccaeee8",
  "productndc": "59676-800",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210455",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;800MG;200MG;EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 17, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE",
  "proprietary_name": "Symtuza",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "NDA210455",
  "marketing_category": "NDA",
  "nonproprietary_name": "Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide",
  "start_marketing_date": "20180717",
  "active_numerator_strength": "150; 800; 200; 10"
}

Related drugs

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