Lurasidone Hydrochloride

Product NDC: 60687-769
Requested package NDC: 60687-769-94
11-digit product format: 606870769
Labeler code: 60687
Product ID: 60687-769_2abe376d-e980-af98-e063-6394a90ac3ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lurasidone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA212244
Marketing category: ANDA
Marketing start: 2023-05-09
Substance: LURASIDONE HYDROCHLORIDE
Active strength: 60 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212244-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13
A212244-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13
A212244-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13
A212244-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13
A212244-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13

Therapeutic equivalence codes#

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

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

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 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2022-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2022-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2022-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-12-13	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212244-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212244-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212244-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212244-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212244-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212244-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212244-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212244-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212244-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212244-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LURASIDONE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O0P4I5851I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1040031	Internal RxNorm lookup
1040041	Internal RxNorm lookup
1235247	Internal RxNorm lookup
1431235	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b83e1015-8016-4c7c-8239-8dba3a882e46	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
86802824-8cc9-f7e2-fc5f-652f1d04e1a2	Product name	8	20250804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-769-11	Lurasidone Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		5
60687-769-94	Lurasidone Hydrochloride	20 in 1 CARTON	TABLET, FILM COATED	20		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-769-11	EA - Each	60687-769	7e87283e-1ec9-43bd-8b62-0fff81ebe1a6	1	2023-05-05
60687-769-94	EA - Each	60687-769	ab5ad194-8e44-4fa7-af4c-97da2fa193cb	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-769	LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5	Current NDC, 2 package rows	20250104_b83e1015-8016-4c7c-8239-8dba3a882e46.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	6008ccac-948e-4b6a-a288-7dd245c2bac4	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Major Pharmaceuticals	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	American Health Packaging	b83e1015-8016-4c7c-8239-8dba3a882e46	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244 ndc (package): 60687-769-94 ndc (product): 60687-769 ndc11 (package): 60687076994
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	A-S Medication Solutions	c96cbfc9-773b-410a-ada3-2822cbd58f8f	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Ascend Laboratories, LLC	36b6bacd-ac11-493b-a8a4-8dad448ed9d5	2023-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212244 application number: ANDA212244

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O0P4I5851I	LURASIDONE HYDROCHLORIDE	367514-88-3	LURASIDONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1235247	lurasidone HCl 20 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040031	lurasidone HCl 40 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1431235	lurasidone HCl 60 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040041	lurasidone HCl 80 MG Oral Tablet	PSN	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040031	lurasidone hydrochloride 40 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1431235	lurasidone hydrochloride 60 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5
1040041	lurasidone hydrochloride 80 MG Oral Tablet	SCD	b83e1015-8016-4c7c-8239-8dba3a882e46	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-769-94	60687076994	20 BLISTER PACK in 1 CARTON (60687-769-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-769-11)	20 blister pack	2023-05-09	No	No	Current