Home NDC 70771-1794 Selexipag
Product NDC 70771-1794
11-digit product format 707711794
Labeler code 70771
Product ID 70771-1794_e39f2aba-4f8f-49d0-82e2-ee509b830d36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Selexipag
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA214302
Marketing category ANDA
Marketing start 2025-02-14
Substance SELEXIPAG
Active strength 400 ug/1
Pharmacologic classes Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70771-1794-6 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70771-1794-6 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70771-1794-6 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70771-1794-6 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70771-1794-6 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70771-1794-6 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214302-001 SELEXIPAG SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 A214302-002 SELEXIPAG SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 A214302-003 SELEXIPAG SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 A214302-004 SELEXIPAG SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 A214302-005 SELEXIPAG SELEXIPAG 1MG TABLET / ORAL 2022-12-21 A214302-006 SELEXIPAG SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 A214302-007 SELEXIPAG SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 A214302-008 SELEXIPAG SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 200 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-001 SELEXIPAG 0.2MG TABLET / ORAL 2022-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-002 SELEXIPAG 0.4MG TABLET / ORAL 2022-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-003 SELEXIPAG 0.6MG TABLET / ORAL 2022-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-004 SELEXIPAG 0.8MG TABLET / ORAL 2022-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-005 SELEXIPAG 1MG TABLET / ORAL 2022-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-006 SELEXIPAG 1.2MG TABLET / ORAL 2022-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-007 SELEXIPAG 1.4MG TABLET / ORAL 2022-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214302-008 SELEXIPAG 1.6MG TABLET / ORAL 2022-12-21 fd3edfee7708…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Selexipag
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SELEXIPAG 400 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5EXC0E384L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 9 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1729007 Internal RxNorm lookup 1729027 Internal RxNorm lookup 1729031 Internal RxNorm lookup 1729045 Internal RxNorm lookup 1729051 Internal RxNorm lookup 1729055 Internal RxNorm lookup 1729059 Internal RxNorm lookup 1729063 Internal RxNorm lookup 1729075 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1794-6 Selexipag 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1794 SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 1 package rows 20250215_ff660787-880f-4f2b-baac-fd2dbfcd79c2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70771-1794-6 70771179406 60 TABLET, FILM COATED in 1 BOTTLE (70771-1794-6) 2025-02-14 Yes No Current