Home NDC 60505-4704-0 TOLVAPTAN
Product NDC 60505-4704
Requested package NDC 60505-4704-0
11-digit product format 605054704
Labeler code 60505
Product ID 60505-4704_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 2020-10-15
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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RS 2009-05-19 N022275-003 SAMSCA TOLVAPTAN 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-05-19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.
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 2026-08-01 22:54:32 2026-06 N022275-001 SAMSCA 15MG TABLET / ORAL AB1 RLD 2009-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N022275-002 SAMSCA 30MG TABLET / ORAL AB1 RLD, RS 2009-05-19 a50c72e98297…2026-08-01 22:54:32 2026-06 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 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N022275-001 AB1 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N022275-002 AB1 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022275-001 8501730 2026-09-01 Drug substance 2013-09-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N022275-001 10905694 2030-04-07 Drug product 2021-02-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N022275-002 8501730 2026-09-01 Drug substance 2013-09-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N022275-002 10905694 2030-04-07 Drug product 2021-02-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N022275-003 8501730 2026-09-01 Drug substance 2013-09-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N022275-003 10905694 2030-04-07 Drug product 2021-02-26 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 60505-4704-0 60505470400 1 BLISTER PACK in 1 CARTON (60505-4704-0) > 10 TABLET in 1 BLISTER PACK 1 blister pack 2020-10-15 0000-00-00 No No Current