Orenitram

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
6630236384
1 KIT in 1 PACKAGE (66302-363-84) * 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 84 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

Orange Book

N203496

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "8ed2003a-c801-411e-831e-d06079bb0d7c": {
      "match": "brand_token",
      "title": "ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE ORENITRAM (TREPROSTINIL) KIT [UNITED THERAPEUTICS CORPORATION]",
      "spl_version": "24",
      "published_date": "2024-12-06"
    }
  },
  "productid": "66302-363_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29",
  "productndc": "66302-363",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203496",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.125MG BASE",
        "product_no": "001",
        "approval_date": "Dec 20, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.25MG BASE",
        "product_no": "002",
        "approval_date": "Dec 20, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "003",
        "approval_date": "Dec 20, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.5MG BASE",
        "product_no": "004",
        "approval_date": "Dec 20, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "005",
        "approval_date": "Oct 7, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Orenitram",
  "active_ingred_unit": null,
  "application_number": "NDA203496",
  "marketing_category": "NDA",
  "nonproprietary_name": "treprostinil",
  "start_marketing_date": "20230214",
  "active_numerator_strength": null
}

Access this data programmatically

Query Orenitram and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs