Orenitram

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 · 2

ndc11
6630230001
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-01)
ndc11
6630230002
1 BLISTER PACK in 1 CARTON (66302-300-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

RUM6K67ESG

TREPROSTINIL

RxCUI 343048

Orange Book

N203496

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": {
    "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": "66302-300_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29",
  "productndc": "66302-300",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "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": "TREPROSTINIL",
  "proprietary_name": "Orenitram",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203496",
  "marketing_category": "NDA",
  "nonproprietary_name": "treprostinil",
  "start_marketing_date": "20131220",
  "active_numerator_strength": ".125"
}

Related drugs

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