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Active ingredient

Tolvaptan

24 finished FDA listings contain Tolvaptan as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TOLVAPTAN
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
8
Strengths listed
15 mg/1 · 30 mg/1 · 45 mg/1 · 60 mg/1 · 90 mg/1
Brand names in FDA listings
Jynarque, Samsca

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 358257

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022275OTSUKA2009-05-192
NDA 204441OTSUKA2018-04-232
ANDA 211891ALKEM LABS LTD2020-05-193
ANDA 207605APOTEX2020-05-192
ANDA 205646HETERO LABS LTD V2021-07-162
ANDA 206119PH HEALTH2022-02-152
ANDA 216949MSN2023-06-214
ANDA 216063LUPIN2025-04-232
ANDA 220147ALKEM LABS LTD2026-04-215

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.