FDA.reportPublic FDA data

Lurasidone Hydrochloride

Product NDC
67046-1637
11-digit product format
670461637
Labeler code
67046
Product ID
67046-1637_4742c86b-0f0d-1222-e063-6394a90a6ab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA213248
Marketing category
ANDA
Marketing start
2025-12-31
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

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
67046-1637-3Lurasidone Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1040031lurasidone HCl 40 MG Oral TabletPSN4742c2fd-303b-da08-e063-6294a90a76211
1040031lurasidone hydrochloride 40 MG Oral TabletSCD4742c2fd-303b-da08-e063-6294a90a76211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1637-36704616370330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1637-3) 2025-12-31NoNoHistorical