Tyvaso DPI

Orange BookUNIISPLATC B01AC21

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

Identification

ManufacturerUnited Therapeutics Corporation

CountryUS (United States)

ATC codeB01AC21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6630276404
1 BLISTER PACK in 1 KIT (66302-764-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

RUM6K67ESG

TREPROSTINIL

RxCUI 343048

Orange Book

N214324

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RUM6K67ESG",
    "rxcui": "343048",
    "inchikey": "PAJMKGZZBBTTOY-ZFORQUDYSA-N",
    "display_name": "TREPROSTINIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "66302-764_81912284-3d3a-430e-a55e-df239b084535",
  "productndc": "66302-764",
  "dosage_form": "INHALANT",
  "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": "TREPROSTINIL",
  "proprietary_name": "Tyvaso DPI",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA214324",
  "marketing_category": "NDA",
  "nonproprietary_name": "treprostinil",
  "start_marketing_date": "20220523",
  "active_numerator_strength": "64"
}

Related drugs

Other records sharing ATC code B01AC21.

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