SOHONOS

Orange BookUNIISPLATC M09AX11

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

Identification

ManufacturerIpsen Biopharmaceuticals, Inc.

CountryUS (United States)

ATC codeM09AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1505401001
1 BLISTER PACK in 1 CARTON (15054-0100-1) / 14 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

28K6I5M16G

PALOVAROTENE

Orange Book

N215559

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "28K6I5M16G",
    "rxcui": null,
    "inchikey": "YTFHCXIPDIHOIA-DHZHZOJOSA-N",
    "display_name": "PALOVAROTENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "67dce406-7cc4-4d66-92de-ad18b6df0625": {
      "match": "brand_token",
      "title": "SOHONOS (PALOVAROTENE) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-03-24"
    }
  },
  "productid": "15054-0100_5bd9a571-7061-4cc7-bda8-18a9976dd427",
  "productndc": "15054-0100",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215559",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 16, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "002",
        "approval_date": "Aug 16, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "003",
        "approval_date": "Aug 16, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Aug 16, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "005",
        "approval_date": "Aug 16, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALOVAROTENE",
  "proprietary_name": "SOHONOS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215559",
  "marketing_category": "NDA",
  "nonproprietary_name": "palovarotene",
  "start_marketing_date": "20230816",
  "active_numerator_strength": "10"
}

Related drugs

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