Sunlenca

Orange BookUNIISPLATC J05AX31

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

Identification

ManufacturerGilead Sciences, Inc.

CountryUS (United States)

ATC codeJ05AX31

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6195830011
1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6195830012
1 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6195830013
4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3)

Annotations

UNII (FDA Substance ID)

BDT58WJ9WE

LENACAPAVIR SODIUM

Orange Book

N215974

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": {
    "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": "61958-3001_12f3f90c-8b72-4e1f-875e-6fcaf4b15959",
  "productndc": "61958-3001",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215974",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 300MG BASE",
        "product_no": "001",
        "approval_date": "Dec 22, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LENACAPAVIR SODIUM",
  "proprietary_name": "Sunlenca",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215974",
  "marketing_category": "NDA",
  "nonproprietary_name": "LENACAPAVIR SODIUM",
  "start_marketing_date": "20221222",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code J05AX31.

Access this data programmatically

Query Sunlenca and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs