TOLVAPTAN

Product NDC: 60505-4705
11-digit product format: 605054705
Labeler code: 60505
Product ID: 60505-4705_1bcbe7de-c01b-4ace-b2cf-8d663b3f92ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tolvaptan
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: NDA022275
Marketing category: NDA
Marketing start: 2020-05-20
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60505-4705		D	Discontinued by firm		2026-08-17
excluded package	package	60505-4705	60505-4705-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-4705-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-4705-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-4705-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-4705-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-4705-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-4705-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-4705-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-4705-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-4705-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-4705-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60505-4705-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60505-4705-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022275-001	SAMSCA	TOLVAPTAN	15MG	TABLET / ORAL	AB1	RLD	2009-05-19
N022275-002	SAMSCA	TOLVAPTAN	30MG	TABLET / ORAL	AB1	RLD, RS	2009-05-19
N022275-003	SAMSCA	TOLVAPTAN	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022275-001	AB1
N022275-002	AB1

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022275-001	8501730	2026-09-01	Drug substance	2013-09-27
N022275-001	10905694	2030-04-07	Drug product	2021-02-26
N022275-002	8501730	2026-09-01	Drug substance	2013-09-27
N022275-002	10905694	2030-04-07	Drug product	2021-02-26
N022275-003	8501730	2026-09-01	Drug substance	2013-09-27
N022275-003	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 4 · 126 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	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB1	RLD	2009-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB1	RLD, RS	2009-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB1	RLD	2009-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB1	RLD, RS	2009-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB1	RLD	2009-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB1	RLD, RS	2009-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB1	RLD	2009-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB1	RLD, RS	2009-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022275-002	SAMSCA	30MG	TABLET / ORAL	AB	RLD, RS	2009-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022275-003	SAMSCA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022275-001	SAMSCA	15MG	TABLET / ORAL	AB	RLD	2009-05-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022275-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022275-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022275-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022275-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022275-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022275-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022275-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022275-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022275-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022275-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022275-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022275-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022275-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022275-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022275-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022275-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022275-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022275-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022275-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022275-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022275-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022275-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022275-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022275-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022275-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022275-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022275-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022275-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022275-002	AB	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 249 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	N022275-001	8501730	2026-09-01	Drug substance	2013-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-001	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-002	8501730	2026-09-01	Drug substance	2013-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-002	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-003	8501730	2026-09-01	Drug substance	2013-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022275-003	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022275-001	8501730	2026-09-01	Drug substance	2013-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-001	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-002	8501730	2026-09-01	Drug substance	2013-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-002	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-003	8501730	2026-09-01	Drug substance	2013-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022275-003	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-001	8501730	2026-09-01	Drug substance	2013-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-001	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-002	8501730	2026-09-01	Drug substance	2013-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-002	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-003	8501730	2026-09-01	Drug substance	2013-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022275-003	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022275-001	8501730	2026-09-01	Drug substance	2013-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-001	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-002	8501730	2026-09-01	Drug substance	2013-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-002	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-003	8501730	2026-09-01	Drug substance	2013-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022275-003	10905694	2030-04-07	Drug product	2021-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-001	8501730	2026-09-01	Drug substance	2013-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-001	10905694	2030-04-07	Drug product	2021-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-002	8501730	2026-09-01	Drug substance	2013-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-002	10905694	2030-04-07	Drug product	2021-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-003	8501730	2026-09-01	Drug substance	2013-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022275-003	10905694	2030-04-07	Drug product	2021-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-001	8501730	2026-09-01	Drug substance	2013-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-001	10905694	2030-04-07	Drug product	2021-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-002	8501730	2026-09-01	Drug substance	2013-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-002	10905694	2030-04-07	Drug product	2021-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-003	8501730	2026-09-01	Drug substance	2013-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022275-003	10905694	2030-04-07	Drug product	2021-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-001	8501730	2026-09-01	Drug substance	2013-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-001	10905694	2030-04-07	Drug product	2021-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-002	8501730	2026-09-01	Drug substance	2013-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022275-002	10905694	2030-04-07	Drug product	2021-02-26	`03ed91905a0d…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4705-0	EA - Each	60505-4705	bd2fab6b-f785-42d6-92ca-248212417bb2	1	2020-06-05

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
SAMSCA	TOLVAPTAN	Otsuka America Pharmaceutical, Inc.	5526617c-c7b9-4556-886d-729bbabbc566	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022275 application number: NDA022275

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-4705-0	60505470500	1 BLISTER PACK in 1 CARTON (60505-4705-0) > 10 TABLET in 1 BLISTER PACK	1 blister pack	2020-05-20	0000-00-00	No	No	Current