Tyvaso DPI

Orange BookSPL

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

Identification

ManufacturerUnited Therapeutics Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6630264003
1 KIT in 1 PACKAGE (66302-640-03) * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK

Annotations

Orange Book

N214324

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "cbc31ab1-a80f-4b50-a3b1-39910b0fb609": {
      "match": "brand_token",
      "title": "TYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORPORATION]",
      "spl_version": "32",
      "published_date": "2026-04-20"
    }
  },
  "productid": "66302-640_81912284-3d3a-430e-a55e-df239b084535",
  "productndc": "66302-640",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214324",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.016MG/INH",
        "product_no": "001",
        "approval_date": "May 23, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.032MG/INH",
        "product_no": "002",
        "approval_date": "May 23, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.048MG/INH",
        "product_no": "003",
        "approval_date": "May 23, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.064MG/INH",
        "product_no": "004",
        "approval_date": "May 23, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.08MG/INH",
        "product_no": "005",
        "approval_date": "Oct 24, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Tyvaso DPI",
  "active_ingred_unit": null,
  "application_number": "NDA214324",
  "marketing_category": "NDA",
  "nonproprietary_name": "treprostinil",
  "start_marketing_date": "20230627",
  "active_numerator_strength": null
}

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