SAMSCA

Product NDC: 59148-021
11-digit product format: 591480021
Labeler code: 59148
Product ID: 59148-021_701668e3-9542-46eb-b6c9-f7553d33385d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tolvaptan
Dosage form: TABLET
Route: ORAL
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA022275
Marketing category: NDA
Marketing start: 2009-05-19
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 · 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N022275-003	SAMSCA	TOLVAPTAN	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-05-19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…`

Additional Listing Data#

Finished product: Yes
Brand name base: SAMSCA
Listing expiration: 2027-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849827	Internal RxNorm lookup
849831	Internal RxNorm lookup
849833	Internal RxNorm lookup
849835	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
5526617c-c7b9-4556-886d-729bbabbc566	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
59148-021-50	SAMSCA	10 in 1 BLISTER PACK	TABLET	10		22
59148-021-50	SAMSCA	1 in 1 CARTON	TABLET	1		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-021-50	EA - Each	59148-021	88b0a932-1045-4bc0-add9-8ec7c9fccf2f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
tolvaptan	ACTIVE INGREDIENT	21G72T1950	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
tolvaptan	ACTIVE MOIETY	21G72T1950	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-021	SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	21	Current NDC, Legacy NDC, 2 package rows	20221119_5526617c-c7b9-4556-886d-729bbabbc566.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
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 ndc (product): 59148-021

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
849831	Samsca 15 MG Oral Tablet	PSN	5526617c-c7b9-4556-886d-729bbabbc566	23
849835	Samsca 30 MG Oral Tablet	PSN	5526617c-c7b9-4556-886d-729bbabbc566	23
849827	tolvaptan 15 MG Hyponatremia Oral Tablet	PSN	5526617c-c7b9-4556-886d-729bbabbc566	23
849833	tolvaptan 30 MG Hyponatremia Oral Tablet	PSN	5526617c-c7b9-4556-886d-729bbabbc566	23
849831	Hyponatremia tolvaptan 15 MG Oral Tablet [Samsca]	SBD	5526617c-c7b9-4556-886d-729bbabbc566	23
849835	Hyponatremia tolvaptan 30 MG Oral Tablet [Samsca]	SBD	5526617c-c7b9-4556-886d-729bbabbc566	23
849827	Hyponatremia tolvaptan 15 MG Oral Tablet	SCD	5526617c-c7b9-4556-886d-729bbabbc566	23
849833	Hyponatremia tolvaptan 30 MG Oral Tablet	SCD	5526617c-c7b9-4556-886d-729bbabbc566	23
849831	Hyponatremia Samsca 15 MG Oral Tablet	SY	5526617c-c7b9-4556-886d-729bbabbc566	23
849835	Hyponatremia Samsca 30 MG Oral Tablet	SY	5526617c-c7b9-4556-886d-729bbabbc566	23
849831	Samsca 15 MG Hyponatremia Oral Tablet	SY	5526617c-c7b9-4556-886d-729bbabbc566	23
849835	Samsca 30 MG Hyponatremia Oral Tablet	SY	5526617c-c7b9-4556-886d-729bbabbc566	23
849827	tolvaptan 15 MG Hyponatremia Oral Tablet	SY	5526617c-c7b9-4556-886d-729bbabbc566	23
849833	tolvaptan 30 MG Hyponatremia Oral Tablet	SY	5526617c-c7b9-4556-886d-729bbabbc566	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59148-021-50	59148002150	1 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK	1 blister pack	2009-05-19	0000-00-00	No	No	Current