Sunlenca

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
6195830021
1 KIT in 1 CARTON (61958-3002-1) * 1.5 mL in 1 VIAL (61958-3004-1)

Annotations

Orange Book

N215973

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "e5652804-29c4-40d7-aeb2-0142ed2a7b5b": {
      "match": "brand_token",
      "title": "SUNLENCA (LENACAPAVIR SODIUM) TABLET, FILM COATED SUNLENCA (LENACAPAVIR SODIUM) KIT [GILEAD SCIENCES, INC.]",
      "spl_version": "12",
      "published_date": "2026-03-26"
    }
  },
  "productid": "61958-3002_12f3f90c-8b72-4e1f-875e-6fcaf4b15959",
  "productndc": "61958-3002",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215973",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 22, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Sunlenca",
  "active_ingred_unit": null,
  "application_number": "NDA215973",
  "marketing_category": "NDA",
  "nonproprietary_name": "LENACAPAVIR SODIUM",
  "start_marketing_date": "20221222",
  "active_numerator_strength": null
}

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