Lurasidone Hydrochloride

Product NDC: 46708-496
11-digit product format: 467080496
Labeler code: 46708
Product ID: 46708-496_a4f0715d-590f-4b13-bb72-19cdca95aa01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lurasidone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA213248
Marketing category: ANDA
Marketing start: 2023-01-24
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 43.

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
A213248-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13
A213248-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13
A213248-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13
A213248-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13
A213248-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213248-001	AB
A213248-002	AB
A213248-003	AB
A213248-004	AB
A213248-005	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 5 · 175 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	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2021-05-13	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 175 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	A213248-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213248-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213248-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213248-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213248-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213248-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213248-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213248-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213248-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213248-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213248-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213248-005	AB	1	`03ed91905a0d…`

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: 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1040031	Internal RxNorm lookup
1040041	Internal RxNorm lookup
1235247	Internal RxNorm lookup
1297278	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
27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-496-10	Lurasidone Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	3
46708-496-10	Lurasidone Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100	3
46708-496-30	Lurasidone Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
46708-496-71	Lurasidone Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
46708-496-90	Lurasidone Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	3
46708-496-91	Lurasidone Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-496	LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 6 package rows	20230126_27f70e15-ee22-47ae-ba87-20e2b4a1a4d6.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	Coupler LLC	4aa17493-69eb-9dc7-e063-6294a90a4c0b	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Coupler LLC	4742c2fd-303b-da08-e063-6294a90a7621	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	1cc441b3-0a23-4c68-a90e-436030b7daf2	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	2023-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213248 application number: ANDA213248 ndc (product): 46708-496

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
1297278	lurasidone HCl 120 MG Oral Tablet	PSN	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1235247	lurasidone HCl 20 MG Oral Tablet	PSN	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1040031	lurasidone HCl 40 MG Oral Tablet	PSN	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1431235	lurasidone HCl 60 MG Oral Tablet	PSN	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1040041	lurasidone HCl 80 MG Oral Tablet	PSN	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1297278	lurasidone hydrochloride 120 MG Oral Tablet	SCD	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1040031	lurasidone hydrochloride 40 MG Oral Tablet	SCD	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1431235	lurasidone hydrochloride 60 MG Oral Tablet	SCD	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3
1040041	lurasidone hydrochloride 80 MG Oral Tablet	SCD	27f70e15-ee22-47ae-ba87-20e2b4a1a4d6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-496-10	46708049610	100 BLISTER PACK in 1 CARTON (46708-496-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2023-01-24	0000-00-00	No	No	Current
46708-496-30	46708049630	30 TABLET, FILM COATED in 1 BOTTLE (46708-496-30)		2023-01-24	0000-00-00	No	No	Current
46708-496-71	46708049671	500 TABLET, FILM COATED in 1 BOTTLE (46708-496-71)		2023-01-24	0000-00-00	No	No	Current
46708-496-90	46708049690	90 TABLET, FILM COATED in 1 BOTTLE (46708-496-90)		2023-01-24	0000-00-00	No	No	Current
46708-496-91	46708049691	1000 TABLET, FILM COATED in 1 BOTTLE (46708-496-91)		2023-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lurasidone Hydrochloride	Alembic Pharmaceuticals Limited	2023-01-25	Human Prescription Drug Label	3