Remodulin

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
6630210501
1 VIAL in 1 BOX (66302-105-01) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

RUM6K67ESG

TREPROSTINIL

RxCUI 343048

Orange Book

N021272

APAPAPAP

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": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "6c80bb38-e8db-4138-9f0d-dbbf9c673185": {
      "match": "brand_token",
      "title": "REMODULIN (TREPROSTINIL) INJECTION, SOLUTION STERILE DILUENT FOR REMODULIN (WATER) INJECTION, SOLUTION [UNITED THERAPEUTICS CORPORATION]",
      "spl_version": "33",
      "published_date": "2025-07-28"
    }
  },
  "productid": "66302-105_143d514e-fdcd-4766-ba47-0a75395e1f84",
  "productndc": "66302-105",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021272",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2.5MG/ML",
        "product_no": "002",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5MG/ML",
        "product_no": "003",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "004",
        "approval_date": "May 21, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/ML",
        "product_no": "005",
        "approval_date": "Jul 30, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.1MG/ML",
        "product_no": "006",
        "approval_date": "Sep 28, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/ML",
        "product_no": "007",
        "approval_date": "Sep 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG/ML",
        "product_no": "008",
        "approval_date": "Sep 28, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TREPROSTINIL",
  "proprietary_name": "Remodulin",
  "active_ingred_unit": "mg/20mL",
  "application_number": "NDA021272",
  "marketing_category": "NDA",
  "nonproprietary_name": "treprostinil",
  "start_marketing_date": "20020522",
  "active_numerator_strength": "100"
}

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