FDA.reportPublic FDA data

LURASIDONE HYDROCHLORIDE

Product NDC
65862-955
11-digit product format
658620955
Labeler code
65862
Product ID
65862-955_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
60 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 HYDROCHLORIDE60 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
65862-955-05LURASIDONE HYDROCHLORIDE500 in 1 BOTTLETABLET5004
65862-955-30LURASIDONE HYDROCHLORIDE30 in 1 BOTTLETABLET304
65862-955-90LURASIDONE HYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-955-30EA - Each65862-9559167febb-bb3d-411d-ab1e-45afe3a374eb12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-955LURASIDONE 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
1431235lurasidone HCl 60 MG Oral TabletPSN4973beed-b75b-c370-e063-6394a90a26e51
1431235lurasidone hydrochloride 60 MG Oral TabletSCD4973beed-b75b-c370-e063-6394a90a26e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65862-955-0565862095505500 TABLET in 1 BOTTLE (65862-955-05) 500 tablet2023-03-10NoNoCurrent
65862-955-15658620955151500 TABLET in 1 BAG (65862-955-15)1500 tablet10-MAR-23Current
65862-955-306586209553030 TABLET in 1 BOTTLE (65862-955-30) 30 tablet2023-03-10NoNoCurrent
65862-955-906586209559090 TABLET in 1 BOTTLE (65862-955-90) 90 tablet2023-03-10NoNoCurrent