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United States · US · US:72964-013_92c4515d-7de1-4bde-9ee9-f350696ba98d

Yutrepia

Orange BookUNIISPLATC B01AC21

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

Identification

ManufacturerLiquidia Technologies, Inc.
CountryUS (United States)
ATC codeB01AC21
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7296401301
    7 BLISTER PACK in 1 CARTON (72964-013-01) / 4 CAPSULE in 1 BLISTER PACK / 1 CAPSULE in 1 CAPSULE

Annotations

UNII (FDA Substance ID)
7JZ75N2NT6
TREPROSTINIL SODIUM
RxCUI 342691
Orange Book
N213005
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7JZ75N2NT6",
    "rxcui": "342691",
    "inchikey": "IQKAWAUTOKVMLE-ZSESPEEFSA-M",
    "display_name": "TREPROSTINIL SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "e8f6d534-115c-440e-bdbb-b443a29bb468": {
      "match": "brand_token",
      "title": "YUTREPIA (TREPROSTINIL) CAPSULE [LIQUIDIA TECHNOLOGIES, INC.]",
      "spl_version": "3",
      "published_date": "2025-09-10"
    }
  },
  "productid": "72964-013_92c4515d-7de1-4bde-9ee9-f350696ba98d",
  "productndc": "72964-013",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213005",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.0265MG BASE/INH",
        "product_no": "001",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.053MG BASE/INH",
        "product_no": "002",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.0795MG BASE/INH",
        "product_no": "003",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.106MG BASE/INH",
        "product_no": "004",
        "approval_date": "May 23, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TREPROSTINIL SODIUM",
  "proprietary_name": "Yutrepia",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA213005",
  "marketing_category": "NDA",
  "nonproprietary_name": "treprostinil",
  "start_marketing_date": "20250523",
  "active_numerator_strength": "79.5"
}

Related drugs

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