Selexipag

Product NDC: 70710-1551
11-digit product format: 707101551
Labeler code: 70710
Product ID: 70710-1551_76164432-4f15-47f2-a3d5-1e46652dc992
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: 200 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

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-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 · 216 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214302-001	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-002	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-003	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-004	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-005	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-006	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-007	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-008	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
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…`

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	200 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
70710-1551-6	Selexipag	60 in 1 BOTTLE	TABLET, FILM COATED	60		3
70710-1551-8	Selexipag	140 in 1 BOTTLE	TABLET, FILM COATED	140		3
70710-1551-8	Selexipag TITRATION PACK	140 in 1 BOTTLE	TABLET, FILM COATED	140	200 ug	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1551	SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS PHARMACEUTICALS (USA) INC.]	3	Current NDC, 2 package rows	20250215_c604e181-e336-4194-bf96-f65dd164d461.zip

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	c604e181-e336-4194-bf96-f65dd164d461	3
1729007	selexipag 1000 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729027	selexipag 1200 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729031	selexipag 1400 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729045	selexipag 1600 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729075	selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration Pack	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729051	selexipag 200 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729055	selexipag 400 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729059	selexipag 600 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729063	selexipag 800 MCG Oral Tablet	PSN	c604e181-e336-4194-bf96-f65dd164d461	3
1729051	selexipag 0.2 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729055	selexipag 0.4 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729059	selexipag 0.6 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729063	selexipag 0.8 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729007	selexipag 1 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729027	selexipag 1.2 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729031	selexipag 1.4 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729045	selexipag 1.6 MG Oral Tablet	SCD	c604e181-e336-4194-bf96-f65dd164d461	3
1729075	{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } Pack	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729007	selexipag 1000 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729027	selexipag 1200 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729031	selexipag 1400 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729045	selexipag 1600 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729051	selexipag 200 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729055	selexipag 400 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729059	selexipag 600 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3
1729063	selexipag 800 MCG Oral Tablet	SY	c604e181-e336-4194-bf96-f65dd164d461	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70710-1551-6	70710155106	60 TABLET, FILM COATED in 1 BOTTLE (70710-1551-6)	2025-02-14	Yes	No	Current
70710-1551-8	70710155108	140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8)	2025-02-14	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Selexipag	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Global FZE \| Zydus Lifesciences Limited	2026-10-01	HUMAN PRESCRIPTION DRUG LABEL	4