LURASIDONE HYDROCHLORIDE

Product NDC: 82804-215
Requested package NDC: 82804-215-30
11-digit product format: 828040215
Labeler code: 82804
Product ID: 82804-215_fa9f0d28-c525-4a1e-acec-84c82e10b9a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LURASIDONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA208045
Marketing category: ANDA
Marketing start: 2023-03-10
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208045-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10
A208045-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10
A208045-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10
A208045-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10
A208045-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208045-001	AB
A208045-002	AB
A208045-003	AB
A208045-004	AB
A208045-005	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 4 · 125 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	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-003	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-004	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-005	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2023-03-10	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 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	A208045-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208045-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208045-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208045-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208045-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208045-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208045-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208045-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208045-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208045-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208045-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208045-005	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: 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
fa9f0d28-c525-4a1e-acec-84c82e10b9a2	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
82804-215-30	LURASIDONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-215-30	EA - Each	82804-215	dbf246d4-357f-482a-8bce-c63b8aa79fd8	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-215	LURASIDONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1	Current NDC, 1 package rows	20250406_fa9f0d28-c525-4a1e-acec-84c82e10b9a2.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	Aurobindo Pharma Limited	b3e9cc86-0c5c-444f-ab57-f4d1a6865035	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208045 application number: ANDA208045
LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	Coupler LLC	4973beed-b75b-c370-e063-6394a90a26e5	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208045 application number: ANDA208045
LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	Proficient Rx LP	fa9f0d28-c525-4a1e-acec-84c82e10b9a2	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208045 application number: ANDA208045 ndc (package): 82804-215-30 ndc (product): 82804-215 ndc11 (package): 82804021530
Lurasidone HCL	LURASIDONE HCL	Direct_rx	296811cf-cba8-16c2-e063-6294a90acfa6	2024-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208045 application number: ANDA208045

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	fa9f0d28-c525-4a1e-acec-84c82e10b9a2	1
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	fa9f0d28-c525-4a1e-acec-84c82e10b9a2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-215-30	82804021530	30 TABLET in 1 BOTTLE (82804-215-30)	30 tablet	2025-03-31	No	No	Current