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United States · US · US:61958-3402_4fcd5eac-41a1-43cd-98c5-f733d5094ff9

Yeztugo

Orange BookSPL

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

Identification

ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6195834021
    1 KIT in 1 CARTON (61958-3402-1) * 1.5 mL in 1 VIAL (61958-3403-1)

Annotations

Orange Book
N220018
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "1c241af1-ce62-4b0a-9eb7-f6b626174f01": {
      "match": "brand_token",
      "title": "YEZTUGO (LENACAPAVIR SODIUM) TABLET, FILM COATED YEZTUGO (LENACAPAVIR SODIUM) KIT [GILEAD SCIENCES, INC.]",
      "spl_version": "4",
      "published_date": "2026-02-17"
    }
  },
  "productid": "61958-3402_4fcd5eac-41a1-43cd-98c5-f733d5094ff9",
  "productndc": "61958-3402",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "220018",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 18, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Yeztugo",
  "active_ingred_unit": null,
  "application_number": "NDA220018",
  "marketing_category": "NDA",
  "nonproprietary_name": "LENACAPAVIR SODIUM",
  "start_marketing_date": "20250618",
  "active_numerator_strength": null
}

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