lurasidone hydrochloride

Product NDC
50090-7170
11-digit product format
500907170
Labeler code
50090
Product ID
50090-7170_d5b325d2-1204-4adb-b105-0bd981f990dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lurasidone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212244
Marketing category
ANDA
Marketing start
2023-01-04
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212244-001LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-13
A212244-002LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-13
A212244-003LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-13
A212244-004LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-13
A212244-005LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212244-001AB
A212244-002AB
A212244-003AB
A212244-004AB
A212244-005AB

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 4 · 125 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-13caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-001LURASIDONE HYDROCHLORIDE20MGTABLET / ORALAB2022-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-002LURASIDONE HYDROCHLORIDE40MGTABLET / ORALAB2022-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-003LURASIDONE HYDROCHLORIDE60MGTABLET / ORALAB2022-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-004LURASIDONE HYDROCHLORIDE80MGTABLET / ORALAB2022-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-005LURASIDONE HYDROCHLORIDE120MGTABLET / ORALAB2022-12-132680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212244-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212244-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212244-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212244-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212244-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212244-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212244-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212244-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212244-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212244-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212244-005AB12680178bc6a6…

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 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
1235247Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c96cbfc9-773b-410a-ada3-2822cbd58f8fAvailable 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
50090-7170-0lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7170-0EA - Each50090-7170d6fb6f1f-c432-40b6-890e-75efd1957f6112024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7170LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240521_c96cbfc9-773b-410a-ada3-2822cbd58f8f.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.6008ccac-948e-4b6a-a288-7dd245c2bac42025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212244
application number: ANDA212244
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEMajor Pharmaceuticalsd8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212244
application number: ANDA212244
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAmerican Health Packagingb83e1015-8016-4c7c-8239-8dba3a882e462025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212244
application number: ANDA212244
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEA-S Medication Solutionsc96cbfc9-773b-410a-ada3-2822cbd58f8f2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212244
application number: ANDA212244
ndc (product): 50090-7170
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEAscend Laboratories, LLC36b6bacd-ac11-493b-a8a4-8dad448ed9d52023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212244
application number: ANDA212244

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235247lurasidone HCl 20 MG Oral TabletPSNc96cbfc9-773b-410a-ada3-2822cbd58f8f1
1235247lurasidone hydrochloride 20 MG Oral TabletSCDc96cbfc9-773b-410a-ada3-2822cbd58f8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7170-05009071700030 TABLET, FILM COATED in 1 BOTTLE (50090-7170-0) 2024-05-15NoNoCurrent