Juxtapid

Orange BookUNIISPLATC C10AX12

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

Identification

ManufacturerChiesi USA, Inc.

CountryUS (United States)

ATC codeC10AX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1012240228
28 CAPSULE in 1 BOTTLE (10122-402-28)

Annotations

UNII (FDA Substance ID)

X4S83CP54E

LOMITAPIDE MESYLATE

RxCUI 1364478

Orange Book

N203858

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "X4S83CP54E",
    "rxcui": "1364478",
    "inchikey": "QKVKOFVWUHNEBX-UHFFFAOYSA-N",
    "display_name": "LOMITAPIDE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "61a0be9d-ee58-43e0-b5cb-141011835081": {
      "match": "brand_token",
      "title": "JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [CHIESI USA, INC.]",
      "spl_version": "25",
      "published_date": "2026-04-02"
    }
  },
  "productid": "10122-402_b2c29de4-7331-4670-998a-69c91ad2fa7f",
  "productndc": "10122-402",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203858",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 21, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Dec 21, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Dec 21, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "004",
        "approval_date": "Apr 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "005",
        "approval_date": "Apr 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "006",
        "approval_date": "Apr 23, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "007",
        "approval_date": "Feb 25, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOMITAPIDE MESYLATE",
  "proprietary_name": "Juxtapid",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203858",
  "marketing_category": "NDA",
  "nonproprietary_name": "lomitapide mesylate",
  "start_marketing_date": "20260225",
  "active_numerator_strength": "2"
}

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