selexipag titration pack

Generic: selexipag

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

Drug Facts

Product Profile

Brand Name selexipag titration pack
Generic Name selexipag
Labeler zydus lifesciences limited
Dosage Form KIT
Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1801
Product ID 70771-1801_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 707711801
Hyphenated Format 70771-1801

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 titration pack (source: ndc)
Generic Name selexipag (source: ndc)
Application Number ANDA214302 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 200 mcg
  • 400 mcg
  • 600 mcg
  • 800 mcg
  • 1000 mcg
  • 1200 mcg
  • 1400 mcg
  • 1600 mcg
source: label
Packaging
  • 1 KIT in 1 CARTON (70771-1801-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70771-1793-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70771-1796-6)
source: ndc

Packages (1)

70771-1801-7 1 KIT in 1 CARTON (70771-1801-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70771-1793-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70771-1796-6)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Selexipag, Selexipag TITRATION PACK ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": false, "description": "1 KIT in 1 CARTON (70771-1801-7)  *  1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70771-1793-8)  *  1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70771-1796-6)", "package_ndc": "70771-1801-7", "marketing_start_date": "20250214"}], "brand_name": "Selexipag TITRATION PACK", "product_id": "70771-1801_e39f2aba-4f8f-49d0-82e2-ee509b830d36", "dosage_form": "KIT", "product_ndc": "70771-1801", "generic_name": "Selexipag", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Selexipag TITRATION PACK", "application_number": "ANDA214302", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}