Lurasidone Hydrochloride

Product NDC
51407-838
11-digit product format
514070838
Labeler code
51407
Product ID
51407-838_4423d3dd-2de0-ff56-e063-6294a90ab1e3
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
2023-02-28
Substance
LURASIDONE HYDROCHLORIDE
Active strength
120 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 HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0P4I5851I
Rxcui1235247, 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
51407-838-05Lurasidone Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-838-05EA - Each51407-8382c0998b0-0cb3-4356-8088-8cf0faf95fa112024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-838LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 1 package rows20250424_1989d512-e568-468f-e063-6294a90a5c22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN1989d512-e568-468f-e063-6294a90a5c224
1235247lurasidone HCl 20 MG Oral TabletPSN1989d512-e568-468f-e063-6294a90a5c224
1431235lurasidone HCl 60 MG Oral TabletPSN1989d512-e568-468f-e063-6294a90a5c224
1297278lurasidone hydrochloride 120 MG Oral TabletSCD1989d512-e568-468f-e063-6294a90a5c224
1235247lurasidone hydrochloride 20 MG Oral TabletSCD1989d512-e568-468f-e063-6294a90a5c224
1431235lurasidone hydrochloride 60 MG Oral TabletSCD1989d512-e568-468f-e063-6294a90a5c224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-838-0551407083805500 TABLET, FILM COATED in 1 BOTTLE (51407-838-05) 2024-02-03NoNoHistorical