Selexipag

Product NDC
70771-1800
11-digit product format
707711800
Labeler code
70771
Product ID
70771-1800_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
1600 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 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 packagepackage70771-1800-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1800-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70771-1800-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70771-1800-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70771-1800-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70771-1800-6cdf11ea48f46…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-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 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-08-23 18:47 UTC2025-08A214302-001SELEXIPAG0.2MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214302-002SELEXIPAG0.4MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214302-003SELEXIPAG0.6MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214302-004SELEXIPAG0.8MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214302-005SELEXIPAG1MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214302-006SELEXIPAG1.2MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214302-007SELEXIPAG1.4MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214302-008SELEXIPAG1.6MGTABLET / ORAL2022-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-001SELEXIPAG0.2MGTABLET / ORAL2022-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-002SELEXIPAG0.4MGTABLET / ORAL2022-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-003SELEXIPAG0.6MGTABLET / ORAL2022-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-004SELEXIPAG0.8MGTABLET / ORAL2022-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-005SELEXIPAG1MGTABLET / ORAL2022-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-006SELEXIPAG1.2MGTABLET / ORAL2022-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-007SELEXIPAG1.4MGTABLET / ORAL2022-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214302-008SELEXIPAG1.6MGTABLET / ORAL2022-12-21fd3edfee7708…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Selexipag
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELEXIPAG1600 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5EXC0E384LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1729007Internal RxNorm lookup
1729027Internal RxNorm lookup
1729031Internal RxNorm lookup
1729045Internal RxNorm lookup
1729051Internal RxNorm lookup
1729055Internal RxNorm lookup
1729059Internal RxNorm lookup
1729063Internal RxNorm lookup
1729075Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff660787-880f-4f2b-baac-fd2dbfcd79c2Available on FDA.report

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
70771-1800-6Selexipag60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1800SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250215_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SelexipagSELEXIPAGZydus Lifesciences Limitedff660787-880f-4f2b-baac-fd2dbfcd79c22025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214302
application number: ANDA214302
ndc (product): 70771-1800
SelexipagSELEXIPAGZydus Pharmaceuticals (USA) Inc.c604e181-e336-4194-bf96-f65dd164d4612024-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214302
application number: ANDA214302

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
70771-1800-67077118000660 TABLET, FILM COATED in 1 BOTTLE (70771-1800-6) 2025-02-14YesNoCurrent