FDA.reportPublic FDA data

Selexipag

Product NDC
70771-1794
11-digit product format
707711794
Labeler code
70771
Product ID
70771-1794_f4bb1da1-5da6-4a87-9886-f417c3f79ba7
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
2027-12-31
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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1794-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1794-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70771-1794-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70771-1794-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70771-1794-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70771-1794-6cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214302-001SELEXIPAGSELEXIPAG0.2MGTABLET / ORAL2022-12-21
A214302-002SELEXIPAGSELEXIPAG0.4MGTABLET / ORAL2022-12-21
A214302-003SELEXIPAGSELEXIPAG0.6MGTABLET / ORAL2022-12-21
A214302-004SELEXIPAGSELEXIPAG0.8MGTABLET / ORAL2022-12-21
A214302-005SELEXIPAGSELEXIPAG1MGTABLET / ORAL2022-12-21
A214302-006SELEXIPAGSELEXIPAG1.2MGTABLET / ORAL2022-12-21
A214302-007SELEXIPAGSELEXIPAG1.4MGTABLET / ORAL2022-12-21
A214302-008SELEXIPAGSELEXIPAG1.6MGTABLET / ORAL2022-12-21

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 6 · 216 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A214302-001SELEXIPAG0.2MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-10-15 13:18:302026-09A214302-002SELEXIPAG0.4MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-10-15 13:18:302026-09A214302-003SELEXIPAG0.6MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-10-15 13:18:302026-09A214302-004SELEXIPAG0.8MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-10-15 13:18:302026-09A214302-005SELEXIPAG1MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-10-15 13:18:302026-09A214302-006SELEXIPAG1.2MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-10-15 13:18:302026-09A214302-007SELEXIPAG1.4MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-10-15 13:18:302026-09A214302-008SELEXIPAG1.6MGTABLET / ORAL2022-12-21c2088c7a36db…
2026-09-14 22:38:342026-08A214302-001SELEXIPAG0.2MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A214302-002SELEXIPAG0.4MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A214302-003SELEXIPAG0.6MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A214302-004SELEXIPAG0.8MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A214302-005SELEXIPAG1MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A214302-006SELEXIPAG1.2MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A214302-007SELEXIPAG1.4MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-09-14 22:38:342026-08A214302-008SELEXIPAG1.6MGTABLET / ORAL2022-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A214302-001SELEXIPAG0.2MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214302-002SELEXIPAG0.4MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214302-003SELEXIPAG0.6MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214302-004SELEXIPAG0.8MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214302-005SELEXIPAG1MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214302-006SELEXIPAG1.2MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214302-007SELEXIPAG1.4MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A214302-008SELEXIPAG1.6MGTABLET / ORAL2022-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214302-001SELEXIPAG0.2MGTABLET / ORAL2022-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214302-002SELEXIPAG0.4MGTABLET / ORAL2022-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214302-003SELEXIPAG0.6MGTABLET / ORAL2022-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214302-004SELEXIPAG0.8MGTABLET / ORAL2022-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214302-005SELEXIPAG1MGTABLET / ORAL2022-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214302-006SELEXIPAG1.2MGTABLET / ORAL2022-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214302-007SELEXIPAG1.4MGTABLET / ORAL2022-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214302-008SELEXIPAG1.6MGTABLET / ORAL2022-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-001SELEXIPAG0.2MGTABLET / ORAL2022-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-002SELEXIPAG0.4MGTABLET / ORAL2022-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-003SELEXIPAG0.6MGTABLET / ORAL2022-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-004SELEXIPAG0.8MGTABLET / ORAL2022-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-005SELEXIPAG1MGTABLET / ORAL2022-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-006SELEXIPAG1.2MGTABLET / ORAL2022-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-007SELEXIPAG1.4MGTABLET / ORAL2022-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214302-008SELEXIPAG1.6MGTABLET / ORAL2022-12-2131067a03dcf5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-05-13 08:27 UTC2023-05A214302-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A214302-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A214302-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A214302-004AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A214302-005AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A214302-006AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A214302-007AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A214302-008AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214302-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214302-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214302-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214302-004AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214302-005AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214302-006AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214302-007AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214302-008AB13bdfa0b2c4d7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Selexipag
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELEXIPAG400 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3940235d-2369-40fe-94e3-68f58494a1a8Product name320250627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1794-6Selexipag60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1794SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250215_ff660787-880f-4f2b-baac-fd2dbfcd79c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729075{140 (selexipag 0.2 MG Oral Tablet) / 60 (selexipag 0.8 MG Oral Tablet) } PackGPCKff660787-880f-4f2b-baac-fd2dbfcd79c22
1729007selexipag 1000 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729027selexipag 1200 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729031selexipag 1400 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729045selexipag 1600 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729075selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration PackPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729051selexipag 200 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729055selexipag 400 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729059selexipag 600 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729063selexipag 800 MCG Oral TabletPSNff660787-880f-4f2b-baac-fd2dbfcd79c22
1729051selexipag 0.2 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729055selexipag 0.4 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729059selexipag 0.6 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729063selexipag 0.8 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729007selexipag 1 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729027selexipag 1.2 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729031selexipag 1.4 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729045selexipag 1.6 MG Oral TabletSCDff660787-880f-4f2b-baac-fd2dbfcd79c22
1729075{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } PackSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729007selexipag 1000 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729027selexipag 1200 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729031selexipag 1400 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729045selexipag 1600 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729051selexipag 200 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729055selexipag 400 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729059selexipag 600 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22
1729063selexipag 800 MCG Oral TabletSYff660787-880f-4f2b-baac-fd2dbfcd79c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1794-67077117940660 TABLET, FILM COATED in 1 BOTTLE (70771-1794-6) 2025-02-14YesNoCurrent