Lurasidone hydrochloride

Product NDC: 70518-4241
Requested package NDC: 70518-4241-0
11-digit product format: 705184241
Labeler code: 70518
Product ID: 70518-4241_5a6e3f7b-61d2-7d83-e063-6394a90afbb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lurasidone hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208047
Marketing category: ANDA
Marketing start: 2024-12-16
Substance: LURASIDONE HYDROCHLORIDE
Active strength: 20 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208047-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24
A208047-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24
A208047-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24
A208047-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A208047-001	AB
A208047-002	AB
A208047-003	AB
A208047-004	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 4 · 140 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
2026-09-14 22:38:34	2026-08	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-08-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208047-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208047-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208047-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208047-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208047-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208047-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208047-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208047-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208047-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208047-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208047-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208047-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208047-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208047-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208047-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208047-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208047-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208047-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208047-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208047-004	AB	1	`5bbf6a4d5a75…`

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
Ingredient	Strength
LURASIDONE HYDROCHLORIDE	20 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1235247	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
a97b59db-29e8-4b00-9d35-56b47335ee25	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
70518-4241-0	Lurasidone hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4241	LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]	1	Current NDC, 1 package rows	20241218_a97b59db-29e8-4b00-9d35-56b47335ee25.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	a97b59db-29e8-4b00-9d35-56b47335ee25	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208047 application number: ANDA208047 ndc (package): 70518-4241-0 ndc (product): 70518-4241 ndc11 (package): 70518424100
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	672d22f6-fad5-49db-9206-f924d02af181	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208047 application number: ANDA208047
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	a101e62e-dd1f-4add-8393-ba6d54adce06	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208047 application number: ANDA208047
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Dr. Reddys Laboratories Inc	9b512af1-98ab-1242-10e8-9534a002306e	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208047 application number: ANDA208047

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	a97b59db-29e8-4b00-9d35-56b47335ee25	3
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	a97b59db-29e8-4b00-9d35-56b47335ee25	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4241-0	70518424100	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4241-0)	2024-12-16	No	No	Current