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Active ingredient

Lubiprostone

43 finished FDA listings contain Lubiprostone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LUBIPROSTONE
Dosage forms
Capsule, Capsule, Gelatin Coated
Routes
Oral
Manufacturers / labelers
19
Strengths listed
.008 mg/1 · .024 mg/1 · 24 ug/1 · 8 ug/1
Brand names in FDA listings
Amitiza, Amitza

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 623033

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 021908SUCAMPO PHARMA LLC2006-01-3125
ANDA 209450AMNEAL2021-11-302
ANDA 209920TEVA PHARMS USA INC2022-01-186
ANDA 214131ZYDUS PHARMS2023-03-236
ANDA 218640ASCENT PHARMS INC2025-01-024

Official labeling on DailyMed

Showing the 12 most recent of 25 labels.

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