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Active ingredient

Dexlansoprazole

22 finished FDA listings contain Dexlansoprazole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DEXLANSOPRAZOLE, DEXLANSOPRAZOLE SESQUIHYDRATE
Dosage forms
Capsule, Delayed Release, Capsule, Delayed Release Pellets
Routes
Oral
Manufacturers / labelers
10
Strengths listed
30 mg/1 · 60 mg/1
Brand names in FDA listings
Dexilant, Dexlansoprazole Delayed Release

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 816346

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 022287TAKEDA PHARMS USA2009-01-303
ANDA 202294PH HEALTH2017-04-195
ANDA 202666TWI PHARMS2022-09-168
ANDA 205205MYLAN2024-01-192
ANDA 219115ALEMBIC2025-11-124

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

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