UPTRAVI

Product NDC: 66215-614
11-digit product format: 662150614
Labeler code: 66215
Product ID: 66215-614_cf17e19e-ac3d-4787-88e8-f4cc7f4fcc74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Selexipag
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Actelion Pharmaceuticals US, Inc.
Application: NDA207947
Marketing category: NDA
Marketing start: 2015-12-21
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207947-001	UPTRAVI	SELEXIPAG	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-002	UPTRAVI	SELEXIPAG	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21
N207947-003	UPTRAVI	SELEXIPAG	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-004	UPTRAVI	SELEXIPAG	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-005	UPTRAVI	SELEXIPAG	1MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-006	UPTRAVI	SELEXIPAG	1.2MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-007	UPTRAVI	SELEXIPAG	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-008	UPTRAVI	SELEXIPAG	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-010	UPTRAVI	SELEXIPAG	0.1MG	TABLET / ORAL		RLD	2026-05-23
N207947-011	UPTRAVI	SELEXIPAG	0.15MG	TABLET / ORAL		RLD	2026-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N207947-001	AB
N207947-002	AB
N207947-003	AB
N207947-004	AB
N207947-005	AB
N207947-006	AB
N207947-007	AB
N207947-008	AB

Orange Book patents#

Current patent rows page 1 of 2 · 120 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207947-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-001	7205302*PED	2027-04-30		Pediatric extension
N207947-001	9173881	2029-08-12	U-1798		2016-01-19
N207947-001	9173881*PED	2030-02-12		Pediatric extension
N207947-001	9284280	2030-06-25	U-1831		2016-04-12
N207947-001	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-001	9284280*PED	2030-12-25		Pediatric extension
N207947-001	8791122*PED	2031-02-01		Pediatric extension
N207947-001	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-001	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-001	10821108*PED	2037-06-01		Pediatric extension
N207947-001	10828298*PED	2037-06-01		Pediatric extension
N207947-002	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-002	7205302*PED	2027-04-30		Pediatric extension
N207947-002	9173881	2029-08-12	U-1798		2016-01-19
N207947-002	9173881*PED	2030-02-12		Pediatric extension
N207947-002	9284280	2030-06-25	U-1831		2016-04-12
N207947-002	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-002	9284280*PED	2030-12-25		Pediatric extension
N207947-002	8791122*PED	2031-02-01		Pediatric extension
N207947-002	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-002	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-002	10821108*PED	2037-06-01		Pediatric extension
N207947-002	10828298*PED	2037-06-01		Pediatric extension
N207947-003	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-003	7205302*PED	2027-04-30		Pediatric extension
N207947-003	9173881	2029-08-12	U-1798		2016-01-19
N207947-003	9173881*PED	2030-02-12		Pediatric extension
N207947-003	9284280	2030-06-25	U-1831		2016-04-12
N207947-003	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-003	9284280*PED	2030-12-25		Pediatric extension
N207947-003	8791122*PED	2031-02-01		Pediatric extension
N207947-003	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-003	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-003	10821108*PED	2037-06-01		Pediatric extension
N207947-003	10828298*PED	2037-06-01		Pediatric extension
N207947-004	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-004	7205302*PED	2027-04-30		Pediatric extension
N207947-004	9173881	2029-08-12	U-1798		2016-01-19
N207947-004	9173881*PED	2030-02-12		Pediatric extension
N207947-004	9284280	2030-06-25	U-1831		2016-04-12
N207947-004	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-004	9284280*PED	2030-12-25		Pediatric extension
N207947-004	8791122*PED	2031-02-01		Pediatric extension
N207947-004	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-004	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-004	10821108*PED	2037-06-01		Pediatric extension
N207947-004	10828298*PED	2037-06-01		Pediatric extension
N207947-005	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-005	7205302*PED	2027-04-30		Pediatric extension
N207947-005	9173881	2029-08-12	U-1798		2016-01-19
N207947-005	9173881*PED	2030-02-12		Pediatric extension
N207947-005	9284280	2030-06-25	U-1831		2016-04-12
N207947-005	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-005	9284280*PED	2030-12-25		Pediatric extension
N207947-005	8791122*PED	2031-02-01		Pediatric extension
N207947-005	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-005	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-005	10821108*PED	2037-06-01		Pediatric extension
N207947-005	10828298*PED	2037-06-01		Pediatric extension
N207947-006	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-006	7205302*PED	2027-04-30		Pediatric extension
N207947-006	9173881	2029-08-12	U-1798		2016-01-19
N207947-006	9173881*PED	2030-02-12		Pediatric extension
N207947-006	9284280	2030-06-25	U-1831		2016-04-12
N207947-006	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-006	9284280*PED	2030-12-25		Pediatric extension
N207947-006	8791122*PED	2031-02-01		Pediatric extension
N207947-006	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-006	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-006	10821108*PED	2037-06-01		Pediatric extension
N207947-006	10828298*PED	2037-06-01		Pediatric extension
N207947-007	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-007	7205302*PED	2027-04-30		Pediatric extension
N207947-007	9173881	2029-08-12	U-1798		2016-01-19
N207947-007	9173881*PED	2030-02-12		Pediatric extension
N207947-007	9284280	2030-06-25	U-1831		2016-04-12
N207947-007	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-007	9284280*PED	2030-12-25		Pediatric extension
N207947-007	8791122*PED	2031-02-01		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 20 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207947-001	NPP	2029-05-23
N207947-001	PED	2029-11-23
N207947-002	NPP	2029-05-23
N207947-002	PED	2029-11-23
N207947-003	NPP	2029-05-23
N207947-003	PED	2029-11-23
N207947-004	NPP	2029-05-23
N207947-004	PED	2029-11-23
N207947-005	NPP	2029-05-23
N207947-005	PED	2029-11-23
N207947-006	NPP	2029-05-23
N207947-006	PED	2029-11-23
N207947-007	NPP	2029-05-23
N207947-007	PED	2029-11-23
N207947-008	NPP	2029-05-23
N207947-008	PED	2029-11-23
N207947-010	NS	2029-05-23
N207947-010	PED	2029-11-23
N207947-011	NS	2029-05-23
N207947-011	PED	2029-11-23

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 9 · 340 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	UPTRAVI	1MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-010	UPTRAVI	0.1MG	TABLET / ORAL		RLD	2026-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-011	UPTRAVI	0.15MG	TABLET / ORAL		RLD	2026-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-007	UPTRAVI	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-008	UPTRAVI	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-001	UPTRAVI	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-002	UPTRAVI	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-003	UPTRAVI	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-004	UPTRAVI	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-005	UPTRAVI	1MG	TABLET / ORAL		RLD	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-006	UPTRAVI	1.2MG	TABLET / ORAL		RLD	2015-12-21	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 146 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N207947-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207947-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207947-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207947-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207947-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207947-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207947-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207947-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207947-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207947-002	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 54 · 2,128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207947-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9284280	2030-06-25	U-1831		2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	8791122	2030-08-01		Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	9284280*PED	2030-12-25		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	8791122*PED	2031-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10821108	2036-12-01	U-2992	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10828298	2036-12-01	U-2991	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10821108*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	10828298*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9284280	2030-06-25	U-1831		2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	8791122	2030-08-01		Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	9284280*PED	2030-12-25		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	8791122*PED	2031-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10821108	2036-12-01	U-2992	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10828298	2036-12-01	U-2991	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10821108*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	10828298*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9284280	2030-06-25	U-1831		2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	8791122	2030-08-01		Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	9284280*PED	2030-12-25		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	8791122*PED	2031-02-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10821108	2036-12-01	U-2992	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10828298	2036-12-01	U-2991	Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10821108*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	10828298*PED	2037-06-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	7205302*PED	2027-04-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	9173881	2029-08-12	U-1798		2016-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	9173881*PED	2030-02-12		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 232 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N207947-001	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-001	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-002	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-003	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-004	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-005	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-006	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-007	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	NPP	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-008	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-010	NS	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-010	PED	2029-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-011	NS	2029-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207947-011	PED	2029-11-23	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-001	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-002	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-003	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-004	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-005	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-006	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-007	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207947-008	ODE-106	2022-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207947-001	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-002	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-003	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-004	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-005	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-006	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-007	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207947-008	ODE-106	2022-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207947-001	ODE-106	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207947-002	ODE-106	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207947-003	ODE-106	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207947-004	ODE-106	2022-12-21	`4b0b4de00fa7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SELEXIPAG	1400 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5EXC0E384L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1729007	Internal RxNorm lookup
1729013	Internal RxNorm lookup
1729027	Internal RxNorm lookup
1729029	Internal RxNorm lookup
1729031	Internal RxNorm lookup
1729033	Internal RxNorm lookup
1729045	Internal RxNorm lookup
1729047	Internal RxNorm lookup
1729051	Internal RxNorm lookup
1729053	Internal RxNorm lookup
1729055	Internal RxNorm lookup
1729057	Internal RxNorm lookup
1729059	Internal RxNorm lookup
1729061	Internal RxNorm lookup
1729063	Internal RxNorm lookup
1729065	Internal RxNorm lookup
1729075	Internal RxNorm lookup
1729076	Internal RxNorm lookup
2565271	Internal RxNorm lookup
2565275	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a7a23b87-f892-4e2c-8e2e-ebf841220f90	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3940235d-2369-40fe-94e3-68f58494a1a8	Product name	3	20250627
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66215-614-06	UPTRAVI	1 in 1 CARTON	TABLET, COATED	1		25
66215-614-06	UPTRAVI	60 in 1 BOTTLE	TABLET, COATED	60		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66215-614-06	EA - Each	66215-614	4d628f03-a37e-4aaa-9188-ad0559b32d73	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66215-614	UPTRAVI (SELEXIPAG) TABLET, COATED UPTRAVI TITRATION PACK (SELEXIPAG) KIT UPTRAVI (SELEXIPAG) INJECTION, POWDER, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.]	24	Current NDC, Legacy NDC, 2 package rows	20240709_a7a23b87-f892-4e2c-8e2e-ebf841220f90.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UPTRAVI	SELEXIPAG	Actelion Pharmaceuticals US, Inc.	a7a23b87-f892-4e2c-8e2e-ebf841220f90	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207947 application number: NDA207947 ndc (product): 66215-614

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
1729076	{140 (selexipag 0.2 MG Oral Tablet [Uptravi]) / 60 (selexipag 0.8 MG Oral Tablet [Uptravi]) } Pack [Uptravi Titration Pack]	BPCK	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729075	{140 (selexipag 0.2 MG Oral Tablet) / 60 (selexipag 0.8 MG Oral Tablet) } Pack	GPCK	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729007	selexipag 1000 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729027	selexipag 1200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729031	selexipag 1400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729045	selexipag 1600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565271	selexipag 1800 MCG Injection	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729075	selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration Pack	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729051	selexipag 200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729055	selexipag 400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729059	selexipag 600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729063	selexipag 800 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	Uptravi 1000 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	Uptravi 1200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729033	Uptravi 1400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729047	Uptravi 1600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	Uptravi 1800 MCG Injection	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	Uptravi 200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	Uptravi 400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	Uptravi 600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	Uptravi 800 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729076	Uptravi Titration Pack	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	selexipag 0.2 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	selexipag 0.4 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	selexipag 0.6 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	selexipag 0.8 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	selexipag 1 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	selexipag 1.2 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729033	selexipag 1.4 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729047	selexipag 1.6 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	selexipag 1.8 MG Injection [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729051	selexipag 0.2 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729055	selexipag 0.4 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729059	selexipag 0.6 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729063	selexipag 0.8 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729007	selexipag 1 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729027	selexipag 1.2 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729031	selexipag 1.4 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729045	selexipag 1.6 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565271	selexipag 1.8 MG Injection	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729076	{140 (selexipag 200 MCG Oral Tablet [Uptravi]) / 60 (selexipag 800 MCG Oral Tablet [Uptravi]) } Pack [Uptravi Titration Pack]	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729075	{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } Pack	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729007	selexipag 1000 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729027	selexipag 1200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729031	selexipag 1400 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729045	selexipag 1600 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729051	selexipag 200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729055	selexipag 400 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729059	selexipag 600 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729063	selexipag 800 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	Uptravi 0.2 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	Uptravi 0.4 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	Uptravi 0.6 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	Uptravi 0.8 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	Uptravi 1 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	Uptravi 1.2 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729033	Uptravi 1.4 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729047	Uptravi 1.6 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	Uptravi 1.8 MG Injection	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	Uptravi 1000 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	Uptravi 1200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	Uptravi 1800 MCG Injection	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	Uptravi 200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	Uptravi 400 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	Uptravi 600 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	Uptravi 800 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729076	Uptravi Titration Pack	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66215-614-06	66215061406	1 BOTTLE in 1 CARTON (66215-614-06) / 60 TABLET, COATED in 1 BOTTLE	1 bottle	2015-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UPTRAVI	Actelion Pharmaceuticals US, Inc. \| Butterworth Laboratories Ltd \| Wickham Micro Limited \| Almac Sciences Limited \| Almac Pharma Services Limited \| EUROFINS AMATSIGROUP SAS \| Eurofins Amatsi Analytics \| SGS Institut Fresenius GmbH \| Excella GmbH & Co. KG \| Konapharma AG \| Confarma France	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	26