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
6630210201
1 VIAL in 1 BOX (66302-102-01) / 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": "66302-102_143d514e-fdcd-4766-ba47-0a75395e1f84",
  "productndc": "66302-102",
  "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": "50"
}

Related drugs

Other records sharing ATC code B01AC21.

Access this data programmatically

Query Remodulin 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