tolvaptan

Product NDC: 60505-4318
Requested package NDC: 60505-4318-3
11-digit product format: 605054318
Labeler code: 60505
Product ID: 60505-4318_690cc374-8439-3e20-77d1-acade3cad332
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tolvaptan
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA207605
Marketing category: ANDA
Marketing start: 2022-07-05
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-4318	60505-4318-3	D	Discontinued by firm		2026-09-09

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 · 12 matching rows.

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

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207605-001	TOLVAPTAN	TOLVAPTAN	30MG	TABLET / ORAL	AB1		2020-05-19
A207605-002	TOLVAPTAN	TOLVAPTAN	15MG	TABLET / ORAL	AB1		2022-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207605-001	AB1
A207605-002	AB1

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 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL		2020-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL		2020-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL		2020-05-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 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	A207605-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207605-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207605-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207605-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207605-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207605-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207605-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207605-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207605-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207605-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207605-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207605-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207605-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207605-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207605-001	AB	1	`782e0a99824c…`
2020-11-12 02:37 UTC	2020-11	A207605-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207605-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207605-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207605-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207605-002	AB	1	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: tolvaptan
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849827	Internal RxNorm lookup
849833	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
d9fd11d0-4269-12fb-95cf-b3c11d75e479	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	SPL version
60505-4318-0	tolvaptan	1 in 1 CARTON	TABLET	1	8
60505-4318-0	tolvaptan	10 in 1 BLISTER PACK	TABLET	10	8
60505-4318-3	tolvaptan	30 in 1 BOTTLE	TABLET	30	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4318-0	EA - Each	60505-4318	8a510075-fc0b-472d-9413-38cfb46fc9e8	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-4318	TOLVAPTAN TABLET [APOTEX CORP.]	7	Current NDC, Legacy NDC, 3 package rows	20241003_d9fd11d0-4269-12fb-95cf-b3c11d75e479.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
tolvaptan	TOLVAPTAN	Apotex Corp.	d9fd11d0-4269-12fb-95cf-b3c11d75e479	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207605 application number: ANDA207605 ndc (package): 60505-4318-3 ndc (product): 60505-4318 ndc11 (package): 60505431803

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
849827	tolvaptan 15 MG Hyponatremia Oral Tablet	PSN	d9fd11d0-4269-12fb-95cf-b3c11d75e479	8
849833	tolvaptan 30 MG Hyponatremia Oral Tablet	PSN	d9fd11d0-4269-12fb-95cf-b3c11d75e479	8
849827	Hyponatremia tolvaptan 15 MG Oral Tablet	SCD	d9fd11d0-4269-12fb-95cf-b3c11d75e479	8
849833	Hyponatremia tolvaptan 30 MG Oral Tablet	SCD	d9fd11d0-4269-12fb-95cf-b3c11d75e479	8
849827	tolvaptan 15 MG Hyponatremia Oral Tablet	SY	d9fd11d0-4269-12fb-95cf-b3c11d75e479	8
849833	tolvaptan 30 MG Hyponatremia Oral Tablet	SY	d9fd11d0-4269-12fb-95cf-b3c11d75e479	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-4318-3	60505431803	30 TABLET in 1 BOTTLE (60505-4318-3)	30 tablet	2022-07-01	0000-00-00	No	No	Current