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United States · US · US:61958-3401_4fcd5eac-41a1-43cd-98c5-f733d5094ff9

Yeztugo

Orange BookUNIISPLATC J05AX31

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

Identification

ManufacturerGilead Sciences, Inc.
CountryUS (United States)
ATC codeJ05AX31
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6195834011
    4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3401-1)

Annotations

UNII (FDA Substance ID)
BDT58WJ9WE
LENACAPAVIR SODIUM
Orange Book
N220020
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BDT58WJ9WE",
    "rxcui": null,
    "inchikey": "SSXPGMNGIORJAQ-PZNXWHLTSA-M",
    "display_name": "LENACAPAVIR SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "61958-3401_4fcd5eac-41a1-43cd-98c5-f733d5094ff9",
  "productndc": "61958-3401",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "220020",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 300MG BASE",
        "product_no": "001",
        "approval_date": "Jun 18, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LENACAPAVIR SODIUM",
  "proprietary_name": "Yeztugo",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA220020",
  "marketing_category": "NDA",
  "nonproprietary_name": "LENACAPAVIR SODIUM",
  "start_marketing_date": "20250618",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code J05AX31.

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