TRYVIO

Product NDC: 80491-8012
Requested package NDC: 80491-8012-8
11-digit product format: 804918012
Labeler code: 80491
Product ID: 80491-8012_44bb9bce-c692-4295-805a-14aed0e7fb04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aprocitentan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Idorsia Pharmaceuticals Ltd
Application: NDA217686
Marketing category: NDA
Marketing start: 2024-03-20
Substance: APROCITENTAN
Active strength: 12.5 mg/1
Pharmacologic classes: Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217686-001	TRYVIO	APROCITENTAN	12.5MG	TABLET / ORAL		RLD, RS	2024-03-19

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16
N217686-001	11174247	2037-11-06	U-3879		2024-04-16
N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16
N217686-001	12297189	2038-02-26		Drug product	2025-06-05
N217686-001	11787782	2038-03-02	U-3877		2024-04-16
N217686-001	11680058	2038-07-26	U-3878		2024-04-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217686-001	NCE	2029-03-22

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217686-001	TRYVIO	12.5MG	TABLET / ORAL	RLD, RS	2024-03-19	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 91 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217686-001	11174247	2037-11-06	U-3879		2024-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217686-001	12297189	2038-02-26		Drug product	2025-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217686-001	11787782	2038-03-02	U-3877		2024-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217686-001	11680058	2038-07-26	U-3878		2024-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217686-001	11174247	2037-11-06	U-3879		2024-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217686-001	12297189	2038-02-26		Drug product	2025-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217686-001	11787782	2038-03-02	U-3877		2024-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217686-001	11680058	2038-07-26	U-3878		2024-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217686-001	11174247	2037-11-06	U-3879		2024-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217686-001	12297189	2038-02-26		Drug product	2025-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217686-001	11787782	2038-03-02	U-3877		2024-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217686-001	11680058	2038-07-26	U-3878		2024-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	11174247	2037-11-06	U-3879		2024-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	12297189	2038-02-26		Drug product	2025-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	11787782	2038-03-02	U-3877		2024-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	11680058	2038-07-26	U-3878		2024-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217686-001	11174247	2037-11-06	U-3879		2024-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217686-001	12297189	2038-02-26		Drug product	2025-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217686-001	11787782	2038-03-02	U-3877		2024-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217686-001	11680058	2038-07-26	U-3878		2024-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217686-001	11174247	2037-11-06	U-3879		2024-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217686-001	11787782	2038-03-02	U-3877		2024-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217686-001	11680058	2038-07-26	U-3878		2024-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217686-001	8324232	2029-09-21	U-3878	Drug substance, Drug product	2024-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217686-001	11174247	2037-11-06	U-3879		2024-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217686-001	10919881	2038-02-26		Drug substance, Drug product	2024-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217686-001	11787782	2038-03-02	U-3877		2024-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217686-001	11680058	2038-07-26	U-3878		2024-04-16	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217686-001	NCE	2029-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217686-001	NCE	2029-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217686-001	NCE	2029-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217686-001	NCE	2029-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217686-001	NCE	2029-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217686-001	NCE	2029-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217686-001	NCE	2029-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217686-001	NCE	2029-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217686-001	NCE	2029-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217686-001	NCE	2029-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217686-001	NCE	2029-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217686-001	NCE	2029-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217686-001	NCE	2029-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217686-001	NCE	2029-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217686-001	NCE	2029-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217686-001	NCE	2029-03-22	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217686-001	NCE	2029-03-22	`a50c72e98297…`

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: TRYVIO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
APROCITENTAN	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MZI81HV01P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2679064	Internal RxNorm lookup
2679070	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
dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5317362-1168-436b-bf02-81fe1473fd99	Product name	1	20250124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80491-8012-3	TRYVIO	1 in 1 CARTON	TABLET, FILM COATED	1	7
80491-8012-3	TRYVIO	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
80491-8012-7	TRYVIO	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	7
80491-8012-8	TRYVIO	1 in 1 CARTON	TABLET, FILM COATED	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80491-8012-3	EA - Each	80491-8012	69cf760a-0887-4ffd-ac26-9fb77dd38fbc	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80491-8012	TRYVIO (APROCITENTAN) TABLET, FILM COATED [IDORSIA PHARMACEUTICALS LTD]	6	Current NDC, 4 package rows	20250417_dfe7a2ee-612c-4aba-834a-d68e6b59a0a6.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
TRYVIO	APROCITENTAN	Idorsia Pharmaceuticals Ltd	dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217686 application number: NDA217686 ndc (package): 80491-8012-8 ndc (product): 80491-8012 ndc11 (package): 80491801208

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MZI81HV01P	APROCITENTAN	1103522-45-7	APROCITENTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2679064	aprocitentan 12.5 MG Oral Tablet	PSN	dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	7
2679070	TRYVIO 12.5 MG Oral Tablet	PSN	dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	7
2679070	aprocitentan 12.5 MG Oral Tablet [Tryvio]	SBD	dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	7
2679064	aprocitentan 12.5 MG Oral Tablet	SCD	dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	7
2679064	aprocitentan 12.5 MG Oral Tablet	SY	dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	7
2679070	Tryvio 12.5 MG Oral Tablet	SY	dfe7a2ee-612c-4aba-834a-d68e6b59a0a6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80491-8012-8	80491801208	1 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7)	1 blister pack	2024-03-20	No	No	Current