Adempas

Product NDC: 50419-252
11-digit product format: 504190252
Labeler code: 50419
Product ID: 50419-252_21ffd9c9-204f-4809-af50-5e6f26e9d4ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: riociguat
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA204819
Marketing category: NDA
Marketing start: 2013-10-08
Substance: RIOCIGUAT
Active strength: 1.5 mg/1
Pharmacologic classes: Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204819-001	ADEMPAS	RIOCIGUAT	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-002	ADEMPAS	RIOCIGUAT	1MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-003	ADEMPAS	RIOCIGUAT	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-004	ADEMPAS	RIOCIGUAT	2MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-005	ADEMPAS	RIOCIGUAT	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N204819-001	AB
N204819-002	AB
N204819-003	AB
N204819-004	AB
N204819-005	AB

Orange Book patents#

Current patent rows page 1 of 1 · 35 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204819-001	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-001	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-001	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-001	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-001	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-001	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-001	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-002	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-002	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-002	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-002	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-002	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-002	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-002	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-003	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-003	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-003	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-003	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-003	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-003	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-003	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-004	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-004	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-004	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-004	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-004	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-004	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-004	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-005	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-005	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-005	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-005	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-005	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-005	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-005	12503469	2034-02-18	U-2835	Drug product	2026-01-21

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 · 220 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
2026-10-15 13:18:30	2026-09	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N204819-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204819-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204819-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204819-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204819-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204819-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204819-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204819-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-005	AB	1	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 4 of 26 · 1,040 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204819-003	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204819-001	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-002	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-003	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-004	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-005	ODE-53	2020-10-08	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204819-001	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-002	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-003	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-004	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-005	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204819-001	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-002	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-003	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-004	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-005	ODE-53	2020-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204819-001	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-002	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-003	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-004	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-005	ODE-53	2020-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204819-001	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-002	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-003	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-004	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-005	ODE-53	2020-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204819-001	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-002	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-003	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-004	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-005	ODE-53	2020-10-08	`ea99ee380514…`

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: Adempas
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIOCIGUAT	1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RU3FE2Y4XI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1439821	Internal RxNorm lookup
1439823	Internal RxNorm lookup
1439831	Internal RxNorm lookup
1439833	Internal RxNorm lookup
1439837	Internal RxNorm lookup
1439894	Internal RxNorm lookup
1439896	Internal RxNorm lookup
1439899	Internal RxNorm lookup
1439901	Internal RxNorm lookup
1439903	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
7b57509a-3d5d-41d4-8fed-1471e26372a3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
68798171-8a97-4b8c-8311-d0ae0c63e4e7	Product name	2	20230627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50419-252-01	Adempas	90 in 1 BOTTLE	TABLET, FILM COATED	90	29
50419-252-03	Adempas	21 in 1 BLISTER PACK	TABLET, FILM COATED	21	29
50419-252-03	Adempas	2 in 1 PACKAGE	TABLET, FILM COATED	2	29
50419-252-91	Adempas	9 in 1 BOTTLE	TABLET, FILM COATED	9	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-252-01	EA - Each	50419-252	f7d2244b-d999-4b5e-b886-ecebc61efec0	1	2013-11-04
50419-252-03	EA - Each	50419-252	fc499f47-e642-4485-9326-35df1012b73c	1	2013-11-04
50419-252-91	EA - Each	50419-252	870fa23b-a6b8-4f8d-8315-edbf6eff328a	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RIOCIGUAT	ACTIVE INGREDIENT	RU3FE2Y4XI	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
RIOCIGUAT	ACTIVE MOIETY	RU3FE2Y4XI	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-252	ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]	20	Current NDC, Legacy NDC, 4 package rows	20241106_7b57509a-3d5d-41d4-8fed-1471e26372a3.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
Adempas	RIOCIGUAT	Bayer HealthCare Pharmaceuticals Inc.	7b57509a-3d5d-41d4-8fed-1471e26372a3	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204819 application number: NDA204819 ndc (product): 50419-252

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU3FE2Y4XI	RIOCIGUAT	625115-55-1	RIOCIGUAT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50419-252-01	50419025201	90 TABLET, FILM COATED in 1 BOTTLE (50419-252-01)		2013-12-08	0000-00-00	No	No	Current
50419-252-03	50419025203	2 BLISTER PACK in 1 PACKAGE (50419-252-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2013-10-08	0000-00-00	No	No	Current
50419-252-91	50419025291	9 TABLET, FILM COATED in 1 BOTTLE (50419-252-91)		2014-09-18	0000-00-00	No	No	Current