Skip to content
LookupMeds

Active ingredient

Lurasidone

138 finished FDA listings contain Lurasidone as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
LURASIDONE, LURASIDONE HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
30
Strengths listed
120 mg/1 · 20 mg/1 · 40 mg/1 · 60 mg/1 · 80 mg/1
Brand names in FDA listings
Latuda

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1040028

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 200603SUNOVION PHARMS INC2010-10-285
ANDA 208028INVAGEN PHARMS2019-01-0310
ANDA 208031LUPIN2019-01-036
ANDA 208002AMNEAL PHARMS CO2019-01-0310
ANDA 208055TORRENT2019-01-036
ANDA 208049ACCORD HLTHCARE2019-01-036
ANDA 208066SUN PHARM2019-01-045
ANDA 208052ZYDUS PHARMS2019-03-1910
ANDA 208058HERITAGE PHARMA AVET2019-09-0410
ANDA 212091CHARTWELL RX2020-12-281
ANDA 213248ALEMBIC2021-05-1312
ANDA 208047DR REDDYS2021-08-247
ANDA 208037MSN2022-09-0910
ANDA 212244ALKEM LABS LTD2022-12-1316
ANDA 208045AUROBINDO PHARMA LTD2023-03-108
ANDA 212124MACLEODS PHARMS2023-06-099
ANDA 218174ANNORA PHARMA2024-08-217

Official labeling on DailyMed

Showing the 12 most recent of 40 labels.

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