JYNARQUE

Product NDC: 59148-083
11-digit product format: 591480083
Labeler code: 59148
Product ID: 59148-083_3be8a6fe-a8d0-43ca-a84d-183b522a3cf4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tolvaptan
Dosage form: TABLET
Route: ORAL
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA204441
Marketing category: NDA
Marketing start: 2018-04-23
Substance: TOLVAPTAN
Active strength: 30 mg/1
Pharmacologic classes: Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 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	AB	RLD, RS	2018-04-23
N204441-004	JYNARQUE	TOLVAPTAN	60MG	TABLET / ORAL	AB2	RLD	2018-04-23
N204441-005	JYNARQUE	TOLVAPTAN	90MG	TABLET / ORAL	AB	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	AB
N204441-004	AB2
N204441-005	AB

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 · 210 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-001	JYNARQUE	15MG	TABLET / ORAL		RLD	2018-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-002	JYNARQUE	30MG	TABLET / ORAL		RLD	2018-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-003	JYNARQUE	45MG	TABLET / ORAL		RLD, RS	2018-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-004	JYNARQUE	60MG	TABLET / ORAL		RLD	2018-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-005	JYNARQUE	90MG	TABLET / ORAL		RLD	2018-04-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 · 415 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2025-08-23 18:47 UTC	2025-08	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 240 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	ODE-178	2025-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	ODE-178	2025-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	ODE-178	2025-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	ODE-178	2025-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	ODE-178	2025-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204441-001	ODE-178	2025-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-002	ODE-178	2025-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-003	ODE-178	2025-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-004	ODE-178	2025-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-005	ODE-178	2025-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-001	ODE-178	2025-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-002	ODE-178	2025-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-003	ODE-178	2025-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-004	ODE-178	2025-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-005	ODE-178	2025-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-001	ODE-178	2025-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-002	ODE-178	2025-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-003	ODE-178	2025-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-004	ODE-178	2025-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-005	ODE-178	2025-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-001	ODE-178	2025-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-002	ODE-178	2025-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-003	ODE-178	2025-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-004	ODE-178	2025-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-005	ODE-178	2025-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-001	ODE-178	2025-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-002	ODE-178	2025-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-003	ODE-178	2025-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-004	ODE-178	2025-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204441-005	ODE-178	2025-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204441-001	ODE-178	2025-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204441-002	ODE-178	2025-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204441-003	ODE-178	2025-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204441-004	ODE-178	2025-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204441-005	ODE-178	2025-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204441-001	ODE-178	2025-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204441-002	ODE-178	2025-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204441-003	ODE-178	2025-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204441-004	ODE-178	2025-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204441-005	ODE-178	2025-04-23	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: JYNARQUE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLVAPTAN	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
21G72T1950	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2044355	Internal RxNorm lookup
2044357	Internal RxNorm lookup
2044359	Internal RxNorm lookup
2044361	Internal RxNorm lookup
2044363	Internal RxNorm lookup
2044365	Internal RxNorm lookup
2044367	Internal RxNorm lookup
2044369	Internal RxNorm lookup
2044966	Internal RxNorm lookup
2044967	Internal RxNorm lookup
2044968	Internal RxNorm lookup
2044969	Internal RxNorm lookup
2044970	Internal RxNorm lookup
2044971	Internal RxNorm lookup
2274813	Internal RxNorm lookup
2274814	Internal RxNorm lookup
2274815	Internal RxNorm lookup
2274816	Internal RxNorm lookup
2719335	Internal RxNorm lookup
2719337	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
3febc0a1-9e5a-4ce0-843d-210f21d862c4	Available on FDA.report

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
59148-083-13	JYNARQUE	1 in 1 CARTON	TABLET	1		19
59148-083-13	JYNARQUE	30 in 1 BOTTLE	TABLET	30		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-083-13	EA - Each	59148-083	46a0346c-10bd-443c-a2ca-d88ec90edc8a	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-083	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

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
Jynarque	TOLVAPTAN	Otsuka America Pharmaceutical, Inc.	3febc0a1-9e5a-4ce0-843d-210f21d862c4	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204441 application number: NDA204441 ndc (product): 59148-083

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
59148-083-13	59148008313	1 BOTTLE in 1 CARTON (59148-083-13) / 30 TABLET in 1 BOTTLE	1 bottle	2018-04-23	0000-00-00	No	No	Current