FDA.reportPublic FDA data

lurasidone hydrochloride

Product NDC
33342-423
11-digit product format
333420423
Labeler code
33342
Product ID
33342-423_61fb32e9-a690-4004-862b-fb4f98b0c04b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA212124
Marketing category
ANDA
Marketing start
2023-06-09
Substance
LURASIDONE HYDROCHLORIDE
Active strength
120 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 HYDROCHLORIDE120 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
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
33342-423-07lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
33342-423-10lurasidone hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-423-07EA - Each33342-42359466f50-4f99-468a-acf2-7d43eac1404912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-423LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 2 package rows20250313_2b07a830-93ba-427a-95fc-5138a6309f1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN2b07a830-93ba-427a-95fc-5138a6309f1e4
1235247lurasidone HCl 20 MG Oral TabletPSN2b07a830-93ba-427a-95fc-5138a6309f1e4
1040031lurasidone HCl 40 MG Oral TabletPSN2b07a830-93ba-427a-95fc-5138a6309f1e4
1431235lurasidone HCl 60 MG Oral TabletPSN2b07a830-93ba-427a-95fc-5138a6309f1e4
1040041lurasidone HCl 80 MG Oral TabletPSN2b07a830-93ba-427a-95fc-5138a6309f1e4
1297278lurasidone hydrochloride 120 MG Oral TabletSCD2b07a830-93ba-427a-95fc-5138a6309f1e4
1235247lurasidone hydrochloride 20 MG Oral TabletSCD2b07a830-93ba-427a-95fc-5138a6309f1e4
1040031lurasidone hydrochloride 40 MG Oral TabletSCD2b07a830-93ba-427a-95fc-5138a6309f1e4
1431235lurasidone hydrochloride 60 MG Oral TabletSCD2b07a830-93ba-427a-95fc-5138a6309f1e4
1040041lurasidone hydrochloride 80 MG Oral TabletSCD2b07a830-93ba-427a-95fc-5138a6309f1e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-423-073334204230730 TABLET, FILM COATED in 1 BOTTLE (33342-423-07) 2023-06-09NoNoCurrent
33342-423-103334204231090 TABLET, FILM COATED in 1 BOTTLE (33342-423-10) 2023-06-09NoNoCurrent