FDA.reportPublic FDA data

lurasidone hydrochloride

Product NDC
0904-7355
11-digit product format
009047355
Labeler code
0904
Product ID
0904-7355_382b3af6-5685-44e2-b310-76fee0d2e0da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA212244
Marketing category
ANDA
Marketing start
2023-01-04
Substance
LURASIDONE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 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
0904-7355-04lurasidone hydrochloride30 in 1 CARTONTABLET, FILM COATED305
0904-7355-04lurasidone hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7355-04EA - Each0904-7355be406ae6-f7bb-4cfc-b5b7-77f44690c88712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7355LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4Current NDC, 2 package rows20241027_d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1235247lurasidone HCl 20 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1040031lurasidone HCl 40 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1431235lurasidone HCl 60 MG Oral TabletPSNd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
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
1040031lurasidone hydrochloride 40 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1431235lurasidone hydrochloride 60 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5
1040041lurasidone hydrochloride 80 MG Oral TabletSCDd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7355-040090473550430 BLISTER PACK in 1 CARTON (0904-7355-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2023-02-20NoNoCurrent