Home NDC 59148-020 SAMSCA
Product NDC 59148-020
11-digit product format 591480020
Labeler code 59148
Product ID 59148-020_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 15 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RS 2009-05-19 N022275-003 SAMSCA TOLVAPTAN 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-05-19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.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code 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.
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 Use code 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 15 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59148-020-50 SAMSCA 10 in 1 BLISTER PACK TABLET 10 22 59148-020-50 SAMSCA 1 in 1 CARTON TABLET 1 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59148-020 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): 59148-020
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59148-020-50 59148002050 1 BLISTER PACK in 1 CARTON (59148-020-50) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2009-05-19 0000-00-00 No No Current