lurasidone hydrochloride

Product NDC
70518-4427
11-digit product format
705184427
Labeler code
70518
Product ID
70518-4427_5b265037-bc4d-467d-e063-6394a90a32f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208031
Marketing category
ANDA
Marketing start
2025-08-06
Substance
LURASIDONE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208031-001LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-03
A208031-002LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-03
A208031-003LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-03
A208031-004LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-03
A208031-005LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208031-001AB
A208031-002AB
A208031-003AB
A208031-004AB
A208031-005AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-0384e616aacf4f…
2026-09-14 22:38:342026-08A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-0384e616aacf4f…
2026-09-14 22:38:342026-08A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-0384e616aacf4f…
2026-09-14 22:38:342026-08A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-0384e616aacf4f…
2026-09-14 22:38:342026-08A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-0384e616aacf4f…
2026-08-18 06:07:402026-07A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2019-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2019-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2019-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2019-01-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2019-01-0303ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208031-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208031-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208031-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208031-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A208031-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A208031-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208031-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208031-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208031-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208031-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208031-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208031-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208031-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208031-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208031-005AB103ed91905a0d…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LURASIDONE HYDROCHLORIDE40 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86802824-8cc9-f7e2-fc5f-652f1d04e1a2Product name820250804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4427-0lurasidone hydrochloride30 in 1 BLISTER PACKTABLET303

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 HYDROCHLORIDELupin Pharmaceuticals, Inc.74f2429b-71df-47f0-9cb5-98685372a9b82025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208031
application number: ANDA208031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1040031lurasidone HCl 40 MG Oral TabletPSN5dc04e98-e41c-40cb-9037-d29084c9bf6d3
1040031lurasidone hydrochloride 40 MG Oral TabletSCD5dc04e98-e41c-40cb-9037-d29084c9bf6d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4427-07051844270030 TABLET in 1 BLISTER PACK (70518-4427-0) 30 tablet2025-08-06NoNoCurrent