FDA.reportPublic FDA data

Lurasidone Hydrochloride

Product NDC
62332-497
11-digit product format
623320497
Labeler code
62332
Product ID
62332-497_2ad2918d-7142-4425-bd00-45a269ef0d61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213248
Marketing category
ANDA
Marketing start
2023-01-24
Substance
LURASIDONE HYDROCHLORIDE
Active strength
80 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 HYDROCHLORIDE80 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
62332-497-10Lurasidone Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED108
62332-497-10Lurasidone Hydrochloride100 in 1 CARTONTABLET, FILM COATED1008
62332-497-30Lurasidone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED308
62332-497-71Lurasidone Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5008
62332-497-90Lurasidone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED908
62332-497-91Lurasidone Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-497-30EA - Each62332-49779a9a790-e784-4333-9922-d9ac4380d60812023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-497LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 6 package rows20250427_1cc441b3-0a23-4c68-a90e-436030b7daf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN1cc441b3-0a23-4c68-a90e-436030b7daf28
1235247lurasidone HCl 20 MG Oral TabletPSN1cc441b3-0a23-4c68-a90e-436030b7daf28
1040031lurasidone HCl 40 MG Oral TabletPSN1cc441b3-0a23-4c68-a90e-436030b7daf28
1431235lurasidone HCl 60 MG Oral TabletPSN1cc441b3-0a23-4c68-a90e-436030b7daf28
1040041lurasidone HCl 80 MG Oral TabletPSN1cc441b3-0a23-4c68-a90e-436030b7daf28
1297278lurasidone hydrochloride 120 MG Oral TabletSCD1cc441b3-0a23-4c68-a90e-436030b7daf28
1235247lurasidone hydrochloride 20 MG Oral TabletSCD1cc441b3-0a23-4c68-a90e-436030b7daf28
1040031lurasidone hydrochloride 40 MG Oral TabletSCD1cc441b3-0a23-4c68-a90e-436030b7daf28
1431235lurasidone hydrochloride 60 MG Oral TabletSCD1cc441b3-0a23-4c68-a90e-436030b7daf28
1040041lurasidone hydrochloride 80 MG Oral TabletSCD1cc441b3-0a23-4c68-a90e-436030b7daf28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-497-1062332049710100 BLISTER PACK in 1 CARTON (62332-497-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2023-01-240000-00-00NoNoCurrent
62332-497-306233204973030 TABLET, FILM COATED in 1 BOTTLE (62332-497-30) 2023-01-240000-00-00NoNoCurrent
62332-497-7162332049771500 TABLET, FILM COATED in 1 BOTTLE (62332-497-71) 2023-01-240000-00-00NoNoCurrent
62332-497-906233204979090 TABLET, FILM COATED in 1 BOTTLE (62332-497-90) 2023-01-240000-00-00NoNoCurrent
62332-497-91623320497911000 TABLET, FILM COATED in 1 BOTTLE (62332-497-91) 2023-01-240000-00-00NoNoCurrent