NDC 59148-082

Jynarque 15 mg tablet

On the label: Otsuka America Pharmaceutical, Inc..

Japan: 4

Where it's made

FactoryWhereRoleLast FDA inspection
Otsuka Pharmaceutical Co LtdItano-gun, JapanMakes it and tests it No problems foundOct 10, 2025 · 5 inspections
Otsuka Pharmaceutical Co LtdTokushima, JapanMakes the active ingredient and tests it Problems found, fixed voluntarilyMar 22, 2024 · 7 inspections
Otsuka Pharmaceutical Co LtdTokushima, JapanMakes it and tests it No problems foundMay 16, 2025 · 6 inspections
Otsuka Pharmaceutical Co., Ltd.Kanzaki-gun, JapanMakes the active ingredient and tests it Problems found, fixed voluntarilyJul 11, 2025 · 6 inspections
AndersonBrecon Inc.Rockford, IL, United StatesPackages it No problems foundAug 19, 2026 · 11 inspections
Boston Analytical Inc dba BA SciencesSalem, NH, United StatesTests it No problems foundMar 7, 2023 · 7 inspections
Eurofins Lancaster Laboratories, LLCLancaster, PA, United StatesTests it Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections
Sharp Packaging Services, LLCConshohocken, PA, United StatesPackages it No problems foundFeb 6, 2026 · 8 inspections
Sharp Packaging Services, LLCAllentown, PA, United StatesPackages it No problems foundNov 21, 2025 · 7 inspections

Product details

Generic drug
Tolvaptan: every company that makes it
Form
tablet, oral
Strength
15 mg
Approval
NDA NDA204441
On the market since
Apr 23, 2018
Package NDCs
59148-082-13
Official label
DailyMed (National Library of Medicine), updated Sep 30, 2026

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