FDA.reportPublic FDA data

Selexipag

Product NDC
70710-1552
11-digit product format
707101552
Labeler code
70710
Product ID
70710-1552_96a3e445-2cb7-4fb5-b95b-3f71f5f72504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selexipag
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
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

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
SELEXIPAG400 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
c604e181-e336-4194-bf96-f65dd164d461Available 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
70710-1552-6Selexipag60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1552SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, 1 package rows20250215_c604e181-e336-4194-bf96-f65dd164d461.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
SelexipagSELEXIPAGZydus Pharmaceuticals (USA) Inc.c604e181-e336-4194-bf96-f65dd164d4612024-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214302
application number: ANDA214302
ndc (product): 70710-1552

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) } PackGPCKc604e181-e336-4194-bf96-f65dd164d4613
1729007selexipag 1000 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729027selexipag 1200 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729031selexipag 1400 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729045selexipag 1600 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729075selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration PackPSNc604e181-e336-4194-bf96-f65dd164d4613
1729051selexipag 200 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729055selexipag 400 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729059selexipag 600 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729063selexipag 800 MCG Oral TabletPSNc604e181-e336-4194-bf96-f65dd164d4613
1729051selexipag 0.2 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729055selexipag 0.4 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729059selexipag 0.6 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729063selexipag 0.8 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729007selexipag 1 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729027selexipag 1.2 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729031selexipag 1.4 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729045selexipag 1.6 MG Oral TabletSCDc604e181-e336-4194-bf96-f65dd164d4613
1729075{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } PackSYc604e181-e336-4194-bf96-f65dd164d4613
1729007selexipag 1000 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729027selexipag 1200 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729031selexipag 1400 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729045selexipag 1600 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729051selexipag 200 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729055selexipag 400 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729059selexipag 600 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613
1729063selexipag 800 MCG Oral TabletSYc604e181-e336-4194-bf96-f65dd164d4613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1552-67071015520660 TABLET, FILM COATED in 1 BOTTLE (70710-1552-6) 2025-02-14YesNoCurrent