FDA.reportPublic FDA data

lurasidone hydrochloride

Product NDC
16729-346
11-digit product format
167290346
Labeler code
16729
Product ID
16729-346_415fe396-0d31-40a9-e063-6294a90a8462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA208049
Marketing category
ANDA
Marketing start
2023-02-20
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
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
16729-346-10lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
16729-346-15lurasidone hydrochloride90 in 1 BOTTLETABLET, FILM COATED907
16729-346-16lurasidone hydrochloride500 in 1 BOTTLETABLET, FILM COATED5007
16729-346-17lurasidone hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007
16729-346-45lurasidone hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
16729-346-46lurasidone hydrochloride10 in 1 CARTONTABLET, FILM COATED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-346LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]6Current NDC, 6 package rows20241006_7e11ec22-63c1-41a6-899c-4fe746f76bd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN7e11ec22-63c1-41a6-899c-4fe746f76bd07
1235247lurasidone HCl 20 MG Oral TabletPSN7e11ec22-63c1-41a6-899c-4fe746f76bd07
1040031lurasidone HCl 40 MG Oral TabletPSN7e11ec22-63c1-41a6-899c-4fe746f76bd07
1431235lurasidone HCl 60 MG Oral TabletPSN7e11ec22-63c1-41a6-899c-4fe746f76bd07
1040041lurasidone HCl 80 MG Oral TabletPSN7e11ec22-63c1-41a6-899c-4fe746f76bd07
1297278lurasidone hydrochloride 120 MG Oral TabletSCD7e11ec22-63c1-41a6-899c-4fe746f76bd07
1235247lurasidone hydrochloride 20 MG Oral TabletSCD7e11ec22-63c1-41a6-899c-4fe746f76bd07
1040031lurasidone hydrochloride 40 MG Oral TabletSCD7e11ec22-63c1-41a6-899c-4fe746f76bd07
1431235lurasidone hydrochloride 60 MG Oral TabletSCD7e11ec22-63c1-41a6-899c-4fe746f76bd07
1040041lurasidone hydrochloride 80 MG Oral TabletSCD7e11ec22-63c1-41a6-899c-4fe746f76bd07
1235247lurasidone HCl 20 MG Oral TabletPSN3cd2da15-4d51-4e5c-b683-1936dc19e2341
1235247lurasidone hydrochloride 20 MG Oral TabletSCD3cd2da15-4d51-4e5c-b683-1936dc19e2341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16729-346-101672903461030 TABLET, FILM COATED in 1 BOTTLE (16729-346-10) 2023-02-20NoNoCurrent
16729-346-151672903461590 in 1 BOTTLEHistorical
16729-346-1616729034616500 in 1 BOTTLEHistorical
16729-346-17167290346171000 in 1 BOTTLEHistorical
16729-346-451672903464510 in 1 BLISTER PACKHistorical
16729-346-461672903464610 in 1 CARTONHistorical