FDA.reportPublic FDA data

Lurasidone Hydrochloride

Product NDC
60687-758
11-digit product format
606870758
Labeler code
60687
Product ID
60687-758_2abe376d-e980-af98-e063-6394a90ac3ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA212244
Marketing category
ANDA
Marketing start
2023-07-03
Substance
LURASIDONE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lurasidone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LURASIDONE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0P4I5851I
Rxcui1040031, 1040041, 1235247, 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
60687-758-11Lurasidone Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED15
60687-758-21Lurasidone Hydrochloride30 in 1 CARTONTABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-758-11EA - Each60687-75829579d8e-f218-4d5b-a786-93436007507e12023-05-05
60687-758-21EA - Each60687-758ca71ac60-60d1-427f-a174-ad21544c416012023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-758LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5Current NDC, 2 package rows20250104_b83e1015-8016-4c7c-8239-8dba3a882e46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235247lurasidone HCl 20 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1040031lurasidone HCl 40 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1431235lurasidone HCl 60 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1040041lurasidone HCl 80 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1235247lurasidone hydrochloride 20 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465
1040031lurasidone hydrochloride 40 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465
1431235lurasidone hydrochloride 60 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465
1040041lurasidone hydrochloride 80 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-758-11606870758111 in 1 BLISTER PACKHistorical
60687-758-216068707582130 BLISTER PACK in 1 CARTON (60687-758-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-758-11) 30 blister pack2023-07-03NoNoHistorical