UPTRAVI

Orange BookUNIISPLATC B01AC27

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

Identification

ManufacturerActelion Pharmaceuticals US, Inc.

CountryUS (United States)

ATC codeB01AC27

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6621561606
1 BOTTLE in 1 CARTON (66215-616-06) / 60 TABLET, COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

5EXC0E384L

SELEXIPAG

RxCUI 1729002

Orange Book

N207947

ABABABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5EXC0E384L",
    "rxcui": "1729002",
    "inchikey": "QXWZQTURMXZVHJ-UHFFFAOYSA-N",
    "display_name": "SELEXIPAG",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a7a23b87-f892-4e2c-8e2e-ebf841220f90": {
      "match": "brand_token",
      "title": "UPTRAVI (SELEXIPAG) TABLET, COATED UPTRAVI TITRATION PACK (SELEXIPAG) KIT UPTRAVI (SELEXIPAG) INJECTION, POWDER, FOR SOLUTION UPTRAVI (SELEXIPAG) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]",
      "spl_version": "26",
      "published_date": "2026-06-01"
    }
  },
  "productid": "66215-616_7c54a125-9778-41f5-b92c-181711e22e06",
  "productndc": "66215-616",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "207947",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.2MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.4MG",
        "product_no": "002",
        "approval_date": "Dec 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.6MG",
        "product_no": "003",
        "approval_date": "Dec 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.8MG",
        "product_no": "004",
        "approval_date": "Dec 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "005",
        "approval_date": "Dec 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1.2MG",
        "product_no": "006",
        "approval_date": "Dec 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1.4MG",
        "product_no": "007",
        "approval_date": "Dec 21, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1.6MG",
        "product_no": "008",
        "approval_date": "Dec 21, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELEXIPAG",
  "proprietary_name": "UPTRAVI",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA207947",
  "marketing_category": "NDA",
  "nonproprietary_name": "Selexipag",
  "start_marketing_date": "20151221",
  "active_numerator_strength": "1600"
}

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