FDA.reportPublic FDA data

Lurasidone hydrochloride

Product NDC
70771-1734
11-digit product format
707711734
Labeler code
70771
Product ID
70771-1734_b82674a0-84e9-4431-9041-e5c360bbdaca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208052
Marketing category
ANDA
Marketing start
2023-02-01
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1734-1Lurasidone hydrochloride100 in 1 BOTTLETABLET, COATED1004
70771-1734-2Lurasidone hydrochloride10 in 1 BLISTER PACKTABLET, COATED104
70771-1734-3Lurasidone hydrochloride30 in 1 BOTTLETABLET, COATED304
70771-1734-4Lurasidone hydrochloride10 in 1 CARTONTABLET, COATED104
70771-1734-5Lurasidone hydrochloride500 in 1 BOTTLETABLET, COATED5004
70771-1734-9Lurasidone hydrochloride90 in 1 BOTTLETABLET, COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1734LURASIDONE HYDROCHLORIDE TABLET, COATED [ZYDUS LIFESCIENCES LIMITED]4Current NDC, 6 package rows20241204_0f5f8228-1304-4981-8577-029136627260.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN0f5f8228-1304-4981-8577-0291366272604
1235247lurasidone HCl 20 MG Oral TabletPSN0f5f8228-1304-4981-8577-0291366272604
1040031lurasidone HCl 40 MG Oral TabletPSN0f5f8228-1304-4981-8577-0291366272604
1431235lurasidone HCl 60 MG Oral TabletPSN0f5f8228-1304-4981-8577-0291366272604
1040041lurasidone HCl 80 MG Oral TabletPSN0f5f8228-1304-4981-8577-0291366272604
1297278lurasidone hydrochloride 120 MG Oral TabletSCD0f5f8228-1304-4981-8577-0291366272604
1235247lurasidone hydrochloride 20 MG Oral TabletSCD0f5f8228-1304-4981-8577-0291366272604
1040031lurasidone hydrochloride 40 MG Oral TabletSCD0f5f8228-1304-4981-8577-0291366272604
1431235lurasidone hydrochloride 60 MG Oral TabletSCD0f5f8228-1304-4981-8577-0291366272604
1040041lurasidone hydrochloride 80 MG Oral TabletSCD0f5f8228-1304-4981-8577-0291366272604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1734-170771173401100 TABLET, COATED in 1 BOTTLE (70771-1734-1) 2023-02-01NoNoHistorical
70771-1734-27077117340210 in 1 BLISTER PACKHistorical
70771-1734-37077117340330 TABLET, COATED in 1 BOTTLE (70771-1734-3) 2023-02-01NoNoHistorical
70771-1734-47077117340410 BLISTER PACK in 1 CARTON (70771-1734-4) / 10 TABLET, COATED in 1 BLISTER PACK (70771-1734-2) 10 blister pack2023-02-01NoNoHistorical
70771-1734-570771173405500 TABLET, COATED in 1 BOTTLE (70771-1734-5) 2023-02-01NoNoHistorical
70771-1734-97077117340990 TABLET, COATED in 1 BOTTLE (70771-1734-9) 2023-02-01NoNoHistorical