uptravi

Generic: selexipag

Labeler: actelion pharmaceuticals us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name uptravi
Generic Name selexipag
Labeler actelion pharmaceuticals us, inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

selexipag 1800 ug/10mL

Manufacturer
Actelion Pharmaceuticals US, Inc.

Identifiers & Regulatory

Product NDC 66215-718
Product ID 66215-718_1cc30c17-fa2f-ad29-e063-6294a90a4f88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214275
Listing Expiration 2026-12-31
Marketing Start 2021-07-29

Pharmacologic Class

Established (EPC)
prostacyclin receptor agonist [epc]
Mechanism of Action
prostacyclin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66215718
Hyphenated Format 66215-718

Supplemental Identifiers

RxCUI
1729007 1729013 1729027 1729029 1729031 1729033 1729045 1729047 1729051 1729053 1729055 1729057 1729059 1729061 1729063 1729065 1729075 1729076 2565271 2565275
UNII
5EXC0E384L
NUI
N0000192339 N0000020068

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name uptravi (source: ndc)
Generic Name selexipag (source: ndc)
Application Number NDA214275 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1800 ug/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

66215-718-01 1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

selexipag (1800 ug/10mL)

Linked Drug Pages (1)

UPTRAVI, UPTRAVI Titration Pack ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1cc30c17-fa2f-ad29-e063-6294a90a4f88", "openfda": {"nui": ["N0000192339", "N0000020068"], "unii": ["5EXC0E384L"], "rxcui": ["1729007", "1729013", "1729027", "1729029", "1729031", "1729033", "1729045", "1729047", "1729051", "1729053", "1729055", "1729057", "1729059", "1729061", "1729063", "1729065", "1729075", "1729076", "2565271", "2565275"], "spl_set_id": ["a7a23b87-f892-4e2c-8e2e-ebf841220f90"], "pharm_class_epc": ["Prostacyclin Receptor Agonist [EPC]"], "pharm_class_moa": ["Prostacyclin Receptor Agonists [MoA]"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "66215-718-01", "marketing_start_date": "20210729"}], "brand_name": "UPTRAVI", "product_id": "66215-718_1cc30c17-fa2f-ad29-e063-6294a90a4f88", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Prostacyclin Receptor Agonist [EPC]", "Prostacyclin Receptor Agonists [MoA]"], "product_ndc": "66215-718", "generic_name": "Selexipag", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UPTRAVI", "active_ingredients": [{"name": "SELEXIPAG", "strength": "1800 ug/10mL"}], "application_number": "NDA214275", "marketing_category": "NDA", "marketing_start_date": "20210729", "listing_expiration_date": "20261231"}