Home DailyMed 88b0a932-1045-4bc0-add9-8ec7c9fccf2f National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:11:49 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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RS 2009-05-19 N022275-003 SAMSCA TOLVAPTAN 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-05-19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 · 132 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 2026-10-15 13:18:30 2026-09 N022275-001 SAMSCA 15MG TABLET / ORAL AB1 RLD 2009-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022275-002 SAMSCA 30MG TABLET / ORAL AB1 RLD, RS 2009-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 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 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 261 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N022275-001 8501730 2026-09-01 Drug substance 2013-09-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022275-001 10905694 2030-04-07 Drug product 2021-02-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022275-002 8501730 2026-09-01 Drug substance 2013-09-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022275-002 10905694 2030-04-07 Drug product 2021-02-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022275-003 8501730 2026-09-01 Drug substance 2013-09-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022275-003 10905694 2030-04-07 Drug product 2021-02-26 c2088c7a36db…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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.