FDA.reportPublic FDA data

Lurasidone hydrochloride

Product NDC
68382-967
11-digit product format
683820967
Labeler code
68382
Product ID
68382-967_4583ae02-09cb-4dd4-b5e7-b3074f3b95aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208052
Marketing category
ANDA
Marketing start
2023-02-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-967-01Lurasidone hydrochloride100 in 1 BOTTLETABLET, COATED1007
68382-967-05Lurasidone hydrochloride500 in 1 BOTTLETABLET, COATED5007
68382-967-06Lurasidone hydrochloride30 in 1 BOTTLETABLET, COATED307
68382-967-16Lurasidone hydrochloride90 in 1 BOTTLETABLET, COATED907
68382-967-30Lurasidone hydrochloride1 in 1 BLISTER PACKTABLET, COATED17
68382-967-77Lurasidone hydrochloride100 in 1 CARTONTABLET, COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-967-06EA - Each68382-967e34838d8-3673-43a2-a31f-7cb5a0491a5d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-967LURASIDONE HYDROCHLORIDE TABLET, COATED [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, 6 package rows20250323_bceb350e-4b88-4de1-9629-9629365a27a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSNbceb350e-4b88-4de1-9629-9629365a27a77
1235247lurasidone HCl 20 MG Oral TabletPSNbceb350e-4b88-4de1-9629-9629365a27a77
1040031lurasidone HCl 40 MG Oral TabletPSNbceb350e-4b88-4de1-9629-9629365a27a77
1431235lurasidone HCl 60 MG Oral TabletPSNbceb350e-4b88-4de1-9629-9629365a27a77
1040041lurasidone HCl 80 MG Oral TabletPSNbceb350e-4b88-4de1-9629-9629365a27a77
1297278lurasidone hydrochloride 120 MG Oral TabletSCDbceb350e-4b88-4de1-9629-9629365a27a77
1235247lurasidone hydrochloride 20 MG Oral TabletSCDbceb350e-4b88-4de1-9629-9629365a27a77
1040031lurasidone hydrochloride 40 MG Oral TabletSCDbceb350e-4b88-4de1-9629-9629365a27a77
1431235lurasidone hydrochloride 60 MG Oral TabletSCDbceb350e-4b88-4de1-9629-9629365a27a77
1040041lurasidone hydrochloride 80 MG Oral TabletSCDbceb350e-4b88-4de1-9629-9629365a27a77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-967-0168382096701100 TABLET, COATED in 1 BOTTLE (68382-967-01) 2023-02-01NoNoHistorical
68382-967-0568382096705500 TABLET, COATED in 1 BOTTLE (68382-967-05) 2023-02-01NoNoHistorical
68382-967-066838209670630 TABLET, COATED in 1 BOTTLE (68382-967-06) 2023-02-01NoNoHistorical
68382-967-166838209671690 TABLET, COATED in 1 BOTTLE (68382-967-16) 2023-02-01NoNoHistorical
68382-967-30683820967301 in 1 BLISTER PACKHistorical
68382-967-7768382096777100 BLISTER PACK in 1 CARTON (68382-967-77) / 1 TABLET, COATED in 1 BLISTER PACK (68382-967-30) 100 blister pack2023-02-01NoNoHistorical