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United States · US · US:61958-3301_30fbf1ef-9467-4632-99b4-9dc8e05506b5

Livdelzi

Orange BookUNIISPLATC A05AX

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

Identification

ManufacturerGilead Sciences, Inc
CountryUS (United States)
ATC codeA05AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6195833011
    30 CAPSULE in 1 BOTTLE (61958-3301-1)
  • ndc11
    6195833012
    30 CAPSULE in 1 BOTTLE (61958-3301-2)

Annotations

UNII (FDA Substance ID)
N1429130KR
SELADELPAR LYSINE
Orange Book
N217899
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N1429130KR",
    "rxcui": null,
    "inchikey": "WTKSWPYGZDCUNQ-JZXFCXSPSA-N",
    "display_name": "SELADELPAR LYSINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "89f79d98-135c-40b2-a585-6996c04e599c": {
      "match": "brand_token",
      "title": "LIVDELZI (SELADELPAR LYSINE) CAPSULE [GILEAD SCIENCES, INC]",
      "spl_version": "3",
      "published_date": "2026-02-10"
    }
  },
  "productid": "61958-3301_30fbf1ef-9467-4632-99b4-9dc8e05506b5",
  "productndc": "61958-3301",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217899",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Aug 14, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELADELPAR LYSINE",
  "proprietary_name": "Livdelzi",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217899",
  "marketing_category": "NDA",
  "nonproprietary_name": "SELADELPAR LYSINE",
  "start_marketing_date": "20240814",
  "active_numerator_strength": "10"
}

Related drugs

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