Home NDC 60505-4705-0 TOLVAPTAN
Product NDC 60505-4705
Requested package NDC 60505-4705-0
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 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 43 .
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RS 2009-05-19 N022275-003 SAMSCA TOLVAPTAN 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-05-19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 · 129 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 2026-09-14 22:38:34 2026-08 N022275-001 SAMSCA 15MG TABLET / ORAL AB1 RLD 2009-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022275-002 SAMSCA 30MG TABLET / ORAL AB1 RLD, RS 2009-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 255 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022275-001 8501730 2026-09-01 Drug substance 2013-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022275-001 10905694 2030-04-07 Drug product 2021-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022275-002 8501730 2026-09-01 Drug substance 2013-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022275-002 10905694 2030-04-07 Drug product 2021-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022275-003 8501730 2026-09-01 Drug substance 2013-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022275-003 10905694 2030-04-07 Drug product 2021-02-26 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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