FDA.reportPublic FDA data

LURASIDONE HYDROCHLORIDE

Product NDC
67046-1654
11-digit product format
670461654
Labeler code
67046
Product ID
67046-1654_4973bdb9-ab5c-58eb-e063-6294a90a883e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LURASIDONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA208045
Marketing category
ANDA
Marketing start
2026-01-28
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
Rxcui1431235

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86802824-8cc9-f7e2-fc5f-652f1d04e1a2Product name820250804
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1654-3LURASIDONE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431235lurasidone HCl 60 MG Oral TabletPSN4973beed-b75b-c370-e063-6394a90a26e51
1431235lurasidone hydrochloride 60 MG Oral TabletSCD4973beed-b75b-c370-e063-6394a90a26e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1654-36704616540330 TABLET in 1 BLISTER PACK (67046-1654-3) 30 tablet2026-01-28NoNoHistorical