Jynarque

Product NDC: 59148-080
11-digit product format: 591480080
Labeler code: 59148
Product ID: 59148-080_44174b92-3ef7-45b0-8f67-016857b8fc3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tolvaptan
Dosage form: KIT
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA204441
Marketing category: NDA
Marketing start: 2020-01-13
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204441-001	JYNARQUE	TOLVAPTAN	15MG	TABLET / ORAL	AB2	RLD	2018-04-23
N204441-002	JYNARQUE	TOLVAPTAN	30MG	TABLET / ORAL	AB2	RLD	2018-04-23
N204441-003	JYNARQUE	TOLVAPTAN	45MG	TABLET / ORAL	AB2	RLD, RS	2018-04-23
N204441-004	JYNARQUE	TOLVAPTAN	60MG	TABLET / ORAL	AB2	RLD	2018-04-23
N204441-005	JYNARQUE	TOLVAPTAN	90MG	TABLET / ORAL	AB2	RLD	2018-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204441-001	AB2
N204441-002	AB2
N204441-003	AB2
N204441-004	AB2
N204441-005	AB2

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204441-001	8501730	2026-09-01	Drug substance	2018-05-21
N204441-001	10905694	2030-04-07	Drug product	2021-02-26
N204441-002	8501730	2026-09-01	Drug substance	2018-05-21
N204441-002	10905694	2030-04-07	Drug product	2021-02-26
N204441-003	8501730	2026-09-01	Drug substance	2018-05-21
N204441-003	10905694	2030-04-07	Drug product	2021-02-26
N204441-004	8501730	2026-09-01	Drug substance	2018-05-21
N204441-004	10905694	2030-04-07	Drug product	2021-02-26
N204441-005	8501730	2026-09-01	Drug substance	2018-05-21
N204441-005	10905694	2030-04-07	Drug product	2021-02-26

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 · 215 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
2026-09-14 22:38:34	2026-08	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB2	RLD, RS	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-001	JYNARQUE	15MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-002	JYNARQUE	30MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-003	JYNARQUE	45MG	TABLET / ORAL		RLD, RS	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-004	JYNARQUE	60MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-005	JYNARQUE	90MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-001	JYNARQUE	15MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-002	JYNARQUE	30MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-003	JYNARQUE	45MG	TABLET / ORAL		RLD, RS	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-004	JYNARQUE	60MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-005	JYNARQUE	90MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-001	JYNARQUE	15MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-002	JYNARQUE	30MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-003	JYNARQUE	45MG	TABLET / ORAL		RLD, RS	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-004	JYNARQUE	60MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-005	JYNARQUE	90MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N204441-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204441-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204441-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204441-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-005	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-001	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-002	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-004	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-005	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 425 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 6 · 240 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-10-29 15:01 UTC	2024-10	N204441-001	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-002	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-003	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-004	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-005	ODE-178	2025-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-001	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-002	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-003	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-004	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-005	ODE-178	2025-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-001	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-002	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-003	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-004	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-005	ODE-178	2025-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-001	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-002	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-003	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-004	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-005	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204441-001	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-002	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-003	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-004	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-005	ODE-178	2025-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-001	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-002	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-003	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-004	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-005	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204441-001	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-002	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-003	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-004	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-005	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204441-001	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-002	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-003	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-004	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-005	ODE-178	2025-04-23	`4b0b4de00fa7…`

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: Jynarque
Listing expiration: 2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7f9e53d9-c2b2-4ac0-9989-193b7a2ecee6	Product name	2	20250805
48801b9b-adbb-003d-f253-aa66331fded9	Product name	5	20240730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59148-080-07	Jynarque	1 in 1 BLISTER PACK	KIT	1		19
59148-080-28	Jynarque	4 in 1 CARTON	KIT	4		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-080-07	EA - Each	59148-080	1fb379a7-892c-4c75-aa11-14e6eeface3a	1	2020-06-05
59148-080-28	EA - Each	59148-080	4bb76830-7d2c-4eaf-9623-0a867a839eca	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-080	JYNARQUE (TOLVAPTAN) KIT JYNARQUE (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20250508_3febc0a1-9e5a-4ce0-843d-210f21d862c4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
21G72T1950	TOLVAPTAN	150683-30-0	tolvaptan

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2274814	{28 (tolvaptan 15 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 30 MG Oral Tablet [Jynarque]) } Pack [Jynarque 30/15 Carton]	BPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044969	{28 (tolvaptan 15 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 45 MG Oral Tablet [Jynarque]) } Pack [Jynarque 45/15 Carton]	BPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044967	{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 60 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]	BPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044971	{28 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 28 (tolvaptan 90 MG Oral Tablet [Jynarque]) } Pack [Jynarque 90/30 Carton]	BPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274816	{56 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 15/15 Carton]	BPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274813	{28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 30 MG Oral Tablet) } Pack	GPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044968	{28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 45 MG Oral Tablet) } Pack	GPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044966	{28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 60 MG Oral Tablet) } Pack	GPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044970	{28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 90 MG Oral Tablet) } Pack	GPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274815	{56 (tolvaptan 15 MG Oral Tablet) } Pack	GPCK	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274816	JYNARQUE 15 MG / 15 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044355	JYNARQUE 15 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274814	JYNARQUE 30 MG / 15 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044357	JYNARQUE 30 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044969	JYNARQUE 45 MG / 15 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044361	JYNARQUE 45 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044967	JYNARQUE 60 MG / 30 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044365	JYNARQUE 60 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044971	JYNARQUE 90 MG / 30 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044369	JYNARQUE 90 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274815	tolvaptan 15 MG / 15 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2719335	tolvaptan 15 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274813	tolvaptan 30 MG / 15 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2719337	tolvaptan 30 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044968	tolvaptan 45 MG / 15 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044359	tolvaptan 45 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044966	tolvaptan 60 MG / 30 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044363	tolvaptan 60 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044970	tolvaptan 90 MG / 30 MG Carton Pack	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044367	tolvaptan 90 MG Oral Tablet	PSN	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044355	tolvaptan 15 MG Oral Tablet [Jynarque]	SBD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044357	tolvaptan 30 MG Oral Tablet [Jynarque]	SBD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044361	tolvaptan 45 MG Oral Tablet [Jynarque]	SBD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044365	tolvaptan 60 MG Oral Tablet [Jynarque]	SBD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044369	tolvaptan 90 MG Oral Tablet [Jynarque]	SBD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2719335	tolvaptan 15 MG Oral Tablet	SCD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2719337	tolvaptan 30 MG Oral Tablet	SCD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044359	tolvaptan 45 MG Oral Tablet	SCD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044363	tolvaptan 60 MG Oral Tablet	SCD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044367	tolvaptan 90 MG Oral Tablet	SCD	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274816	4 {14 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 15/15 Carton]	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274815	4 {14 (tolvaptan 15 MG Oral Tablet) } Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274814	4 {7 (tolvaptan 30 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 45/15 Carton]	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274813	4 {7 (tolvaptan 30 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044969	4 {7 (tolvaptan 45 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 15 MG Oral Tablet [Jynarque]) } Pack [Jynarque 45/15 Carton]	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044968	4 {7 (tolvaptan 45 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044967	4 {7 (tolvaptan 60 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 30 MG Oral Tablet [Jynarque]) } Pack [Jynarque 60/30 Carton]	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044966	4 {7 (tolvaptan 60 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044971	4 {7 (tolvaptan 90 MG Oral Tablet [Jynarque]) / 7 (tolvaptan 30 MG Oral Tablet [Jynarque]) } Pack [Jynarque 90/30 Carton]	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044970	4 {7 (tolvaptan 90 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274816	Jynarque 15 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Capsules Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044355	Jynarque 15 MG Oral Tablet	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274814	Jynarque 30 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Capsules Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044357	Jynarque 30 MG Oral Tablet	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044969	Jynarque 45 MG / 15 MG Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044969	Jynarque 45 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Capsules Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044361	Jynarque 45 MG Oral Tablet	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044967	Jynarque 60 MG / 30 MG Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044967	Jynarque 60 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Capsules Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044365	Jynarque 60 MG Oral Tablet	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044971	Jynarque 90 MG / 30 MG Carton Pack	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044971	Jynarque 90 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Capsules Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044369	Jynarque 90 MG Oral Tablet	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274815	tolvaptan 15 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2274813	tolvaptan 30 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044968	tolvaptan 45 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044966	tolvaptan 60 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19
2044970	tolvaptan 90 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets Each	SY	3febc0a1-9e5a-4ce0-843d-210f21d862c4	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59148-080-07	59148008007	1 in 1 BLISTER PACK						Historical
59148-080-28	59148008028	4 BLISTER PACK in 1 CARTON (59148-080-28) / 1 KIT in 1 BLISTER PACK (59148-080-07)	4 blister pack	2020-01-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Jynarque	Otsuka America Pharmaceutical, Inc. \| Otsuka Pharmaceutical Co Ltd \| Boston Analytical Inc \| AndersonBrecon Inc \| Eurofins Lancaster Laboratories, Inc \| Sharp Packaging Services, LLC	2026-09-30	HUMAN PRESCRIPTION DRUG LABEL	21