UPTRAVI Titration Pack

Orange BookSPL

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

Identification

ManufacturerActelion Pharmaceuticals US, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6621562820
1 KIT in 1 CARTON (66215-628-20) * 1 BOTTLE in 1 CARTON / 140 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 60 TABLET, COATED in 1 BOTTLE

Annotations

Orange Book

N207947

ABABABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "66215-628_7c54a125-9778-41f5-b92c-181711e22e06",
  "productndc": "66215-628",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "UPTRAVI Titration Pack",
  "active_ingred_unit": null,
  "application_number": "NDA207947",
  "marketing_category": "NDA",
  "nonproprietary_name": "Selexipag",
  "start_marketing_date": "20151221",
  "active_numerator_strength": null
}

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