uptravi titration pack

Generic: selexipag

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

Drug Facts

Product Profile

Brand Name uptravi titration pack
Generic Name selexipag
Labeler actelion pharmaceuticals us, inc.
Dosage Form KIT
Manufacturer
Actelion Pharmaceuticals US, Inc.

Identifiers & Regulatory

Product NDC 66215-628
Product ID 66215-628_1cc30c17-fa2f-ad29-e063-6294a90a4f88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207947
Listing Expiration 2026-12-31
Marketing Start 2015-12-21

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 66215628
Hyphenated Format 66215-628

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 titration pack (source: ndc)
Generic Name selexipag (source: ndc)
Application Number NDA207947 (source: ndc)
Routes
oral intravenous
source: label

Resolved Composition

Strengths
  • 200 mcg
  • 400 mcg
  • 600 mcg
  • 800 mcg
  • 1000 mcg
  • 1200 mcg
  • 1400 mcg
  • 1600 mcg
  • 1800 mcg
  • 10 ml
source: label
Packaging
  • 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
source: ndc

Packages (1)

66215-628-20 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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

UPTRAVI, UPTRAVI Titration Pack ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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 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", "package_ndc": "66215-628-20", "marketing_start_date": "20151221"}], "brand_name": "UPTRAVI Titration Pack", "product_id": "66215-628_1cc30c17-fa2f-ad29-e063-6294a90a4f88", "dosage_form": "KIT", "product_ndc": "66215-628", "generic_name": "Selexipag", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UPTRAVI Titration Pack", "application_number": "NDA207947", "marketing_category": "NDA", "marketing_start_date": "20151221", "listing_expiration_date": "20261231"}