Lurasidone Hydrochloride

Product NDC
23155-889
11-digit product format
231550889
Labeler code
23155
Product ID
23155-889_19a66177-342e-464d-82b1-47bdf9735233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA208058
Marketing category
ANDA
Marketing start
2023-10-19
Marketing end
2028-06-30
Substance
LURASIDONE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage23155-88923155-889-05DDiscontinued by firm2026-10-23
excluded packagepackage23155-88923155-889-09DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-2623155-889-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2623155-889-09f5e01cc5f278…a2eaf40c39c3…
2025-03-22 03:12 UTC · source 2025-03-2123155-889-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2123155-889-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1023155-889-09cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1023155-889-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3123155-889-09302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3123155-889-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2023155-889-09ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2023155-889-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1023155-889-090efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1023155-889-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0823155-889-09ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0823155-889-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0323155-889-09367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0323155-889-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0923155-889-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0923155-889-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208058-001LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-04
A208058-002LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-04
A208058-003LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-04
A208058-004LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-04
A208058-005LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A208058-001AB
A208058-002AB
A208058-003AB
A208058-004AB
A208058-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 198 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-04c2088c7a36db…
2026-10-15 13:18:302026-09A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-04c2088c7a36db…
2026-10-15 13:18:302026-09A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-04c2088c7a36db…
2026-10-15 13:18:302026-09A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-04c2088c7a36db…
2026-10-15 13:18:302026-09A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-28c2088c7a36db…
2026-09-14 22:38:342026-08A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-0484e616aacf4f…
2026-09-14 22:38:342026-08A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-0484e616aacf4f…
2026-09-14 22:38:342026-08A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-0484e616aacf4f…
2026-09-14 22:38:342026-08A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-0484e616aacf4f…
2026-09-14 22:38:342026-08A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2023-02-28b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A208058-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208058-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208058-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208058-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208058-005AB1c2088c7a36db…
2026-09-14 22:38:342026-08A208058-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208058-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208058-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208058-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A208058-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A208058-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208058-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208058-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208058-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208058-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208058-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208058-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208058-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208058-005AB1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lurasidone Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LURASIDONE HYDROCHLORIDE60 mg/1

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
23155-889-03Lurasidone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
23155-889-05Lurasidone Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
23155-889-09Lurasidone Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906
23155-889-18Lurasidone Hydrochloride40000 in 1 CONTAINERTABLET, FILM COATED400006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-889-03EA - Each23155-8899fb340eb-ff20-4fe2-ac10-fdd9c15fa67712025-09-12
23155-889-18EA - Each23155-889d1f3ff46-cb92-4e4f-bda9-0a75a08ba97512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-889LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMA LABS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, 4 package rows20250323_083a1a52-5a13-4e28-8ef2-127ac4ce5b2d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEGolden State Medical Supply, Inc.1989d512-e568-468f-e063-6294a90a5c222026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208058
application number: ANDA208058

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297278lurasidone HCl 120 MG Oral TabletPSN083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1235247lurasidone HCl 20 MG Oral TabletPSN083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1040031lurasidone HCl 40 MG Oral TabletPSN083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1431235lurasidone HCl 60 MG Oral TabletPSN083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1040041lurasidone HCl 80 MG Oral TabletPSN083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1297278lurasidone hydrochloride 120 MG Oral TabletSCD083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1235247lurasidone hydrochloride 20 MG Oral TabletSCD083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1040031lurasidone hydrochloride 40 MG Oral TabletSCD083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1431235lurasidone hydrochloride 60 MG Oral TabletSCD083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
1040041lurasidone hydrochloride 80 MG Oral TabletSCD083a1a52-5a13-4e28-8ef2-127ac4ce5b2d6
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 startMarketing endSampleExclude flagStatus
23155-889-032315508890330 TABLET, FILM COATED in 1 BOTTLE (23155-889-03) 2023-10-192028-06-30NoNoHistorical
23155-889-0523155088905500 in 1 BOTTLEHistorical
23155-889-092315508890990 in 1 BOTTLEHistorical
23155-889-182315508891840000 TABLET, FILM COATED in 1 CONTAINER (23155-889-18) 2023-10-192027-01-31NoNoHistorical