Selexipag

Product NDC: 70771-1799
Requested package NDC: 70771-1799-6
11-digit product format: 707711799
Labeler code: 70771
Product ID: 70771-1799_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: 1400 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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	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 6 · 208 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214302-001	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-002	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-003	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-004	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-005	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-006	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-007	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-008	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A214302-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-004	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-006	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-007	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-008	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214302-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-004	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-005	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-006	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-007	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-008	AB	1	`3bdfa0b2c4d7…`

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
Ingredient	Strength
SELEXIPAG	1400 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3940235d-2369-40fe-94e3-68f58494a1a8	Product name	3	20250627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1799-6	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
70771-1799	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Selexipag	SELEXIPAG	Zydus Lifesciences Limited	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214302 application number: ANDA214302 ndc (package): 70771-1799-6 ndc (product): 70771-1799 ndc11 (package): 70771179906
Selexipag	SELEXIPAG	Zydus Pharmaceuticals (USA) Inc.	c604e181-e336-4194-bf96-f65dd164d461	2024-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214302 application number: ANDA214302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5EXC0E384L	SELEXIPAG	475086-01-2	SELEXIPAG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1729075	{140 (selexipag 0.2 MG Oral Tablet) / 60 (selexipag 0.8 MG Oral Tablet) } Pack	GPCK	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729007	selexipag 1000 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729027	selexipag 1200 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729031	selexipag 1400 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729045	selexipag 1600 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729075	selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration Pack	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729051	selexipag 200 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729055	selexipag 400 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729059	selexipag 600 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729063	selexipag 800 MCG Oral Tablet	PSN	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729051	selexipag 0.2 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729055	selexipag 0.4 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729059	selexipag 0.6 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729063	selexipag 0.8 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729007	selexipag 1 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729027	selexipag 1.2 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729031	selexipag 1.4 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729045	selexipag 1.6 MG Oral Tablet	SCD	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729075	{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } Pack	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729007	selexipag 1000 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729027	selexipag 1200 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729031	selexipag 1400 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729045	selexipag 1600 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729051	selexipag 200 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729055	selexipag 400 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729059	selexipag 600 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2
1729063	selexipag 800 MCG Oral Tablet	SY	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70771-1799-6	70771179906	60 TABLET, FILM COATED in 1 BOTTLE (70771-1799-6)	2025-02-14	Yes	No	Current