FDA.reportPublic FDA data

lurasidone hydrochloride

Product NDC
72205-209
11-digit product format
722050209
Labeler code
72205
Product ID
72205-209_8f42d8c8-cccf-49e3-9bad-e9a45d8d7896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA208037
Marketing category
ANDA
Marketing start
2023-02-09
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
72205-209-05lurasidone hydrochloride500 in 1 BOTTLETABLET, FILM COATED5003
72205-209-30lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
72205-209-90lurasidone hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-209-30EA - Each72205-209ca09d43e-4ad6-46df-899e-a9a508f525f612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-209LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, 3 package rows20241023_4f969224-a9f0-4089-84d6-a15664ea7bfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN4f969224-a9f0-4089-84d6-a15664ea7bfe3
1235247lurasidone HCl 20 MG Oral TabletPSN4f969224-a9f0-4089-84d6-a15664ea7bfe3
1040031lurasidone HCl 40 MG Oral TabletPSN4f969224-a9f0-4089-84d6-a15664ea7bfe3
1431235lurasidone HCl 60 MG Oral TabletPSN4f969224-a9f0-4089-84d6-a15664ea7bfe3
1040041lurasidone HCl 80 MG Oral TabletPSN4f969224-a9f0-4089-84d6-a15664ea7bfe3
1297278lurasidone hydrochloride 120 MG Oral TabletSCD4f969224-a9f0-4089-84d6-a15664ea7bfe3
1235247lurasidone hydrochloride 20 MG Oral TabletSCD4f969224-a9f0-4089-84d6-a15664ea7bfe3
1040031lurasidone hydrochloride 40 MG Oral TabletSCD4f969224-a9f0-4089-84d6-a15664ea7bfe3
1431235lurasidone hydrochloride 60 MG Oral TabletSCD4f969224-a9f0-4089-84d6-a15664ea7bfe3
1040041lurasidone hydrochloride 80 MG Oral TabletSCD4f969224-a9f0-4089-84d6-a15664ea7bfe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-209-0572205020905500 TABLET, FILM COATED in 1 BOTTLE (72205-209-05) 2023-02-20NoNoCurrent
72205-209-307220502093030 TABLET, FILM COATED in 1 BOTTLE (72205-209-30) 2023-02-20NoNoCurrent
72205-209-907220502099090 TABLET, FILM COATED in 1 BOTTLE (72205-209-90) 2023-02-20NoNoCurrent