FDA.reportPublic FDA data

lurasidone hydrochloride

Product NDC
67877-639
11-digit product format
678770639
Labeler code
67877
Product ID
67877-639_6e4065a5-2672-4ef4-996d-f9d2f58970d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA212244
Marketing category
ANDA
Marketing start
2023-01-04
Substance
LURASIDONE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-639-05lurasidone hydrochloride500 in 1 BOTTLETABLET, FILM COATED5008
67877-639-30lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED308
67877-639-33lurasidone hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED108
67877-639-38lurasidone hydrochloride10 in 1 CARTONTABLET, FILM COATED108
67877-639-90lurasidone hydrochloride90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-639-30EA - Each67877-63982813e1f-03d7-434c-b845-16ac73e0b6d912023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-639LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 5 package rows20230107_36b6bacd-ac11-493b-a8a4-8dad448ed9d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1235247lurasidone HCl 20 MG Oral TabletPSN36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1040031lurasidone HCl 40 MG Oral TabletPSN36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1431235lurasidone HCl 60 MG Oral TabletPSN36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1040041lurasidone HCl 80 MG Oral TabletPSN36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1297278lurasidone hydrochloride 120 MG Oral TabletSCD36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1235247lurasidone hydrochloride 20 MG Oral TabletSCD36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1040031lurasidone hydrochloride 40 MG Oral TabletSCD36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1431235lurasidone hydrochloride 60 MG Oral TabletSCD36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1040041lurasidone hydrochloride 80 MG Oral TabletSCD36b6bacd-ac11-493b-a8a4-8dad448ed9d58
1297278lurasidone HCl 120 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1235247lurasidone HCl 20 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1235247lurasidone HCl 20 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1040031lurasidone HCl 40 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1040031lurasidone HCl 40 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1431235lurasidone HCl 60 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1431235lurasidone HCl 60 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1040041lurasidone HCl 80 MG Oral TabletPSNb83e1015-8016-4c7c-8239-8dba3a882e465
1040041lurasidone HCl 80 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1297278lurasidone hydrochloride 120 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1235247lurasidone hydrochloride 20 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1235247lurasidone hydrochloride 20 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465
1040031lurasidone hydrochloride 40 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1040031lurasidone hydrochloride 40 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465
1431235lurasidone hydrochloride 60 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1431235lurasidone hydrochloride 60 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465
1040041lurasidone hydrochloride 80 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1040041lurasidone hydrochloride 80 MG Oral TabletSCDb83e1015-8016-4c7c-8239-8dba3a882e465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-639-0567877063905500 TABLET, FILM COATED in 1 BOTTLE (67877-639-05) 2023-01-040000-00-00NoNoCurrent
67877-639-306787706393030 TABLET, FILM COATED in 1 BOTTLE (67877-639-30) 2023-01-040000-00-00NoNoCurrent
67877-639-336787706393310 in 1 BLISTER PACKHistorical
67877-639-386787706393810 BLISTER PACK in 1 CARTON (67877-639-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-639-33) 10 blister pack2023-01-040000-00-00NoNoCurrent
67877-639-906787706399090 TABLET, FILM COATED in 1 BOTTLE (67877-639-90) 2023-01-040000-00-00NoNoCurrent