Lurasidone Hydrochloride

Product NDC
70518-4491
11-digit product format
705184491
Labeler code
70518
Product ID
70518-4491_407c6e44-e2fc-7523-e063-6394a90af312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lurasidone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA218174
Marketing category
ANDA
Marketing start
2025-10-04
Substance
LURASIDONE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A218174-001LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-21
A218174-002LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-21
A218174-003LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-21
A218174-004LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-21
A218174-005LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218174-001AB
A218174-002AB
A218174-003AB
A218174-004AB
A218174-005AB

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 2 · 55 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2024-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2024-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2024-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2024-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2024-08-215bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 55 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218174-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218174-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218174-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218174-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218174-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218174-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218174-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218174-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Lurasidone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LURASIDONE HYDROCHLORIDE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O0P4I5851IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1040031Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b94e9272-ed67-4af8-827a-4b8cc3b168a1Available on FDA.report

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
70518-4491-0Lurasidone Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.0115b2fa-4c11-4f91-abe7-8293903e066c2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218174
application number: ANDA218174
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.b94e9272-ed67-4af8-827a-4b8cc3b168a12025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218174
application number: ANDA218174
ndc (product): 70518-4491
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECamber Pharmaceuticals, Inc.c80625bb-7857-4763-81fe-542b3448d84f2025-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218174
application number: ANDA218174

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1040031lurasidone HCl 40 MG Oral TabletPSNb94e9272-ed67-4af8-827a-4b8cc3b168a11
1040031lurasidone hydrochloride 40 MG Oral TabletSCDb94e9272-ed67-4af8-827a-4b8cc3b168a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4491-07051844910030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4491-0) 2025-10-04NoNoCurrent