FDA.reportPublic FDA data

LURASIDONE HYDROCHLORIDE

Product NDC
65862-956
11-digit product format
658620956
Labeler code
65862
Product ID
65862-956_b73e1972-e96d-4463-ad39-f7bed99466e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LURASIDONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA208045
Marketing category
ANDA
Marketing start
2023-03-10
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
65862-956-05LURASIDONE HYDROCHLORIDE500 in 1 BOTTLETABLET5004
65862-956-30LURASIDONE HYDROCHLORIDE30 in 1 BOTTLETABLET304
65862-956-90LURASIDONE HYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-956-30EA - Each65862-9565dbcf0ce-ca37-492f-a6d5-49873240e92e12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-956LURASIDONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]4Current NDC, 3 package rows20250321_b3e9cc86-0c5c-444f-ab57-f4d1a6865035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSNb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1235247lurasidone HCl 20 MG Oral TabletPSNb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1040031lurasidone HCl 40 MG Oral TabletPSNb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1431235lurasidone HCl 60 MG Oral TabletPSNb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1040041lurasidone HCl 80 MG Oral TabletPSNb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1297278lurasidone hydrochloride 120 MG Oral TabletSCDb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1235247lurasidone hydrochloride 20 MG Oral TabletSCDb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1040031lurasidone hydrochloride 40 MG Oral TabletSCDb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1431235lurasidone hydrochloride 60 MG Oral TabletSCDb3e9cc86-0c5c-444f-ab57-f4d1a68650354
1040041lurasidone hydrochloride 80 MG Oral TabletSCDb3e9cc86-0c5c-444f-ab57-f4d1a68650354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65862-956-0565862095605500 TABLET in 1 BOTTLE (65862-956-05) 500 tablet2023-03-10NoNoHistorical
65862-956-306586209563030 TABLET in 1 BOTTLE (65862-956-30) 30 tablet2023-03-10NoNoHistorical
65862-956-906586209569090 TABLET in 1 BOTTLE (65862-956-90) 90 tablet2023-03-10NoNoHistorical