FDA.reportPublic FDA data

Lurasidone Hydrochloride

Product NDC
13668-737
11-digit product format
136680737
Labeler code
13668
Product ID
13668-737_e535c6d5-718e-489b-ad51-7d34dfabcec5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA208055
Marketing category
ANDA
Marketing start
2026-03-02
Substance
LURASIDONE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lurasidone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LURASIDONE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0P4I5851I
Rxcui1040031, 1040041, 1235247, 1297278, 1431235

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86802824-8cc9-f7e2-fc5f-652f1d04e1a2Product name820250804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-737-30Lurasidone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3012
13668-737-90Lurasidone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-737LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, 2 package rows20250509_9cb5e275-1029-407a-8c93-ec5cde2d323b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN9cb5e275-1029-407a-8c93-ec5cde2d323b12
1235247lurasidone HCl 20 MG Oral TabletPSN9cb5e275-1029-407a-8c93-ec5cde2d323b12
1040031lurasidone HCl 40 MG Oral TabletPSN9cb5e275-1029-407a-8c93-ec5cde2d323b12
1431235lurasidone HCl 60 MG Oral TabletPSN9cb5e275-1029-407a-8c93-ec5cde2d323b12
1040041lurasidone HCl 80 MG Oral TabletPSN9cb5e275-1029-407a-8c93-ec5cde2d323b12
1297278lurasidone hydrochloride 120 MG Oral TabletSCD9cb5e275-1029-407a-8c93-ec5cde2d323b12
1235247lurasidone hydrochloride 20 MG Oral TabletSCD9cb5e275-1029-407a-8c93-ec5cde2d323b12
1040031lurasidone hydrochloride 40 MG Oral TabletSCD9cb5e275-1029-407a-8c93-ec5cde2d323b12
1431235lurasidone hydrochloride 60 MG Oral TabletSCD9cb5e275-1029-407a-8c93-ec5cde2d323b12
1040041lurasidone hydrochloride 80 MG Oral TabletSCD9cb5e275-1029-407a-8c93-ec5cde2d323b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-737-301366807373030 TABLET, FILM COATED in 1 BOTTLE (13668-737-30) 2026-03-02NoNoHistorical
13668-737-901366807379090 TABLET, FILM COATED in 1 BOTTLE (13668-737-90) 2026-03-02NoNoHistorical