Lurasidone Hydrochloride

Product NDC
51407-832
11-digit product format
514070832
Labeler code
51407
Product ID
51407-832_4655e19e-554d-0a05-e063-6294a90ab7a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA208058
Marketing category
ANDA
Marketing start
2019-09-04
Marketing end
2026-09-30
Substance
LURASIDONE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lurasidone Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LURASIDONE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0P4I5851I
Rxcui1040031, 1040041

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
51407-832-05Lurasidone Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-832-05EA - Each51407-8322e976559-30a8-4b6e-a051-a0048869d34d12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-832LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20231101_08ba1a4c-c193-e0ea-e063-6294a90a52dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1040031lurasidone HCl 40 MG Oral TabletPSN08ba1a4c-c193-e0ea-e063-6294a90a52dc2
1040041lurasidone HCl 80 MG Oral TabletPSN08ba1a4c-c193-e0ea-e063-6294a90a52dc2
1040031lurasidone hydrochloride 40 MG Oral TabletSCD08ba1a4c-c193-e0ea-e063-6294a90a52dc2
1040041lurasidone hydrochloride 80 MG Oral TabletSCD08ba1a4c-c193-e0ea-e063-6294a90a52dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-832-0551407083205500 TABLET, FILM COATED in 1 BOTTLE (51407-832-05) 2023-10-232026-09-30NoNoHistorical