OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Selexipag TITRATION PACK

Selexipag · Kit

Prescription ANDA TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Selexipag TITRATION PACK
Generic name
Selexipag
Dosage form
Kit
Route
—
Marketing category
ANDA · ANDA
Labeler
Zydus Pharmaceuticals (USA) Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
214302
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 21, 2022
Sponsor
ZYDUS LIFESCIENCES
Products on application
8
Submissions recorded
1
Products approved under application 214302.
Product Trade name Form Strength Ingredient Status TE Flags
214302-001 SELEXIPAG TABLET SELEXIPAG Discontinued AB
214302-002 SELEXIPAG TABLET SELEXIPAG Discontinued AB
214302-003 SELEXIPAG TABLET SELEXIPAG Discontinued AB
214302-004 SELEXIPAG TABLET SELEXIPAG Discontinued AB
214302-005 SELEXIPAG TABLET SELEXIPAG Discontinued AB
214302-006 SELEXIPAG TABLET SELEXIPAG Discontinued AB
214302-007 SELEXIPAG TABLET SELEXIPAG Discontinued AB
214302-008 SELEXIPAG TABLET SELEXIPAG Discontinued AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 214302.
Type No. Action Status Date Review
Original application 1 Approved December 21, 2022 Standard

Review documents

  • 0 · Original application · January 10, 2023
  • 0 · Original application · August 25, 2022

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
70771-1801-7 70771-1801 Zydus Lifesciences Limited 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) February 14, 2025
70710-1653-7 70710-1653 Zydus Pharmaceuticals (USA) Inc. 1 KIT in 1 CARTON (70710-1653-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70710-1554-6) February 14, 2025
70771-1801 70771-1801 Zydus Lifesciences Limited — February 14, 2025
70710-1653 70710-1653 Zydus Pharmaceuticals (USA) Inc. — February 14, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 7 sections on this page.