selexipag

Generic: selexipag

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name selexipag
Generic Name selexipag
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

selexipag 600 ug/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1795
Product ID 70771-1795_e39f2aba-4f8f-49d0-82e2-ee509b830d36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214302
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

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 707711795
Hyphenated Format 70771-1795

Supplemental Identifiers

RxCUI
1729007 1729027 1729031 1729045 1729051 1729055 1729059 1729063 1729075
UPC
0370771179763 0370771179466 0370771180066 0370771179664 0370771179862 0370771179565 0370771179367 0370771179961
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 selexipag (source: ndc)
Generic Name selexipag (source: ndc)
Application Number ANDA214302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 ug/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (70771-1795-6)
source: ndc

Packages (1)

70771-1795-6 60 TABLET, FILM COATED in 1 BOTTLE (70771-1795-6)

Ingredients (1)

selexipag (600 ug/1)

Linked Drug Pages (1)

Selexipag, Selexipag TITRATION PACK ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e39f2aba-4f8f-49d0-82e2-ee509b830d36", "openfda": {"nui": ["N0000192339", "N0000020068"], "upc": ["0370771179763", "0370771179466", "0370771180066", "0370771179664", "0370771179862", "0370771179565", "0370771179367", "0370771179961"], "unii": ["5EXC0E384L"], "rxcui": ["1729007", "1729027", "1729031", "1729045", "1729051", "1729055", "1729059", "1729063", "1729075"], "spl_set_id": ["ff660787-880f-4f2b-baac-fd2dbfcd79c2"], "pharm_class_epc": ["Prostacyclin Receptor Agonist [EPC]"], "pharm_class_moa": ["Prostacyclin Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "60 TABLET, FILM COATED in 1 BOTTLE (70771-1795-6)", "package_ndc": "70771-1795-6", "marketing_start_date": "20250214"}], "brand_name": "Selexipag", "product_id": "70771-1795_e39f2aba-4f8f-49d0-82e2-ee509b830d36", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Prostacyclin Receptor Agonist [EPC]", "Prostacyclin Receptor Agonists [MoA]"], "product_ndc": "70771-1795", "generic_name": "Selexipag", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Selexipag", "active_ingredients": [{"name": "SELEXIPAG", "strength": "600 ug/1"}], "application_number": "ANDA214302", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}