Latuda

Product NDC: 63402-304
11-digit product format: 634020304
Labeler code: 63402
Product ID: 63402-304_7383b0e0-01e8-4778-96f0-6f2e0c9586ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lurasidone hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sumitomo Pharma America, Inc.
Application: NDA200603
Marketing category: NDA
Marketing start: 2010-10-28
Substance: LURASIDONE HYDROCHLORIDE
Active strength: 40 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 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	RLD / RS	Approval date
N200603-001	LATUDA	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28
N200603-002	LATUDA	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RLD	2010-10-28
N200603-003	LATUDA	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RLD	2011-12-07
N200603-004	LATUDA	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	RLD	2012-04-26
N200603-005	LATUDA	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	RLD	2013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200603-001	AB
N200603-002	AB
N200603-003	AB
N200603-004	AB
N200603-005	AB

Orange Book patents#

Current patent rows page 1 of 1 · 55 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200603-001	8729085	2026-05-26		Drug product	2014-05-29
N200603-001	8883794	2026-05-26		Drug product	2014-11-12
N200603-001	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-001	9907794	2026-05-26		Drug product	2018-03-19
N200603-001	8729085*PED	2026-11-26		Pediatric extension
N200603-001	8883794*PED	2026-11-26		Pediatric extension
N200603-001	9907794*PED	2026-11-26		Pediatric extension
N200603-001	9259423	2031-05-23	U-1822		2016-03-15
N200603-001	9827242	2031-05-23	U-2199		2017-12-19
N200603-001	9827242	2031-05-23	U-2201		2017-12-19
N200603-001	9259423*PED	2031-11-23		Pediatric extension
N200603-002	8729085	2026-05-26		Drug product	2014-05-29
N200603-002	8883794	2026-05-26		Drug product	2014-11-12
N200603-002	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-002	9907794	2026-05-26		Drug product	2018-03-19
N200603-002	8729085*PED	2026-11-26		Pediatric extension
N200603-002	8883794*PED	2026-11-26		Pediatric extension
N200603-002	9907794*PED	2026-11-26		Pediatric extension
N200603-002	9259423	2031-05-23	U-1822		2016-03-15
N200603-002	9827242	2031-05-23	U-2199		2017-12-19
N200603-002	9827242	2031-05-23	U-2201		2017-12-19
N200603-002	9259423*PED	2031-11-23		Pediatric extension
N200603-003	8729085	2026-05-26		Drug product	2014-05-29
N200603-003	8883794	2026-05-26		Drug product	2014-11-12
N200603-003	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-003	9907794	2026-05-26		Drug product	2018-03-19
N200603-003	8729085*PED	2026-11-26		Pediatric extension
N200603-003	8883794*PED	2026-11-26		Pediatric extension
N200603-003	9907794*PED	2026-11-26		Pediatric extension
N200603-003	9259423	2031-05-23	U-1822		2016-03-15
N200603-003	9827242	2031-05-23	U-2199		2017-12-19
N200603-003	9827242	2031-05-23	U-2201		2017-12-19
N200603-003	9259423*PED	2031-11-23		Pediatric extension
N200603-004	8729085	2026-05-26		Drug product	2014-05-29
N200603-004	8883794	2026-05-26		Drug product	2014-11-12
N200603-004	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-004	9907794	2026-05-26		Drug product	2018-03-19
N200603-004	8729085*PED	2026-11-26		Pediatric extension
N200603-004	8883794*PED	2026-11-26		Pediatric extension
N200603-004	9907794*PED	2026-11-26		Pediatric extension
N200603-004	9259423	2031-05-23	U-1822		2016-03-15
N200603-004	9827242	2031-05-23	U-2199		2017-12-19
N200603-004	9827242	2031-05-23	U-2201		2017-12-19
N200603-004	9259423*PED	2031-11-23		Pediatric extension
N200603-005	8729085	2026-05-26		Drug product	2014-05-29
N200603-005	8883794	2026-05-26		Drug product	2014-11-12
N200603-005	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-005	9907794	2026-05-26		Drug product	2018-03-19
N200603-005	8729085*PED	2026-11-26		Pediatric extension
N200603-005	8883794*PED	2026-11-26		Pediatric extension
N200603-005	9907794*PED	2026-11-26		Pediatric extension
N200603-005	9259423	2031-05-23	U-1822		2016-03-15
N200603-005	9827242	2031-05-23	U-2199		2017-12-19
N200603-005	9827242	2031-05-23	U-2201		2017-12-19
N200603-005	9259423*PED	2031-11-23		Pediatric extension

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N200603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-005	AB	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 82 · 3,275 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200603-001	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9259423	2031-05-23	U-1822		2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9827242	2031-05-23	U-2199		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9827242	2031-05-23	U-2201		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9259423*PED	2031-11-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9259423	2031-05-23	U-1822		2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9827242	2031-05-23	U-2201		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9827242	2031-05-23	U-2199		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9259423*PED	2031-11-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9259423	2031-05-23	U-1822		2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9827242	2031-05-23	U-2199		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9827242	2031-05-23	U-2201		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9259423*PED	2031-11-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N200603-001	M-195	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	NPP	2021-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-002	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-002	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-002	NPP	2021-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	M-195	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	NPP	2021-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	M-195	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	NPP	2021-03-05	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N200603-001	NPP	2021-03-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200603-002	NPP	2021-03-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200603-003	NPP	2021-03-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200603-005	NPP	2021-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-001	NPP	2021-03-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-002	NPP	2021-03-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-003	NPP	2021-03-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-005	NPP	2021-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200603-001	NPP	2021-03-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200603-002	NPP	2021-03-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200603-003	NPP	2021-03-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200603-005	NPP	2021-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200603-001	M-195	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	NPP	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	NPP	2021-03-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-002	NPP	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-002	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-002	NPP	2021-03-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-003	M-195	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-003	NPP	2020-01-27	`8869cabd3fbd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Latuda
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LURASIDONE HYDROCHLORIDE	40 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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1040031	Internal RxNorm lookup
1040036	Internal RxNorm lookup
1040041	Internal RxNorm lookup
1040043	Internal RxNorm lookup
1235247	Internal RxNorm lookup
1235249	Internal RxNorm lookup
1297278	Internal RxNorm lookup
1297357	Internal RxNorm lookup
1431235	Internal RxNorm lookup
1431237	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
afad3051-9df2-4c54-9684-e8262a133af8	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	SPL version
63402-304-01	Latuda	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	37
63402-304-04	Latuda	4 in 1 CARTON	TABLET, FILM COATED	4	37
63402-304-07	Latuda	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	37
63402-304-10	Latuda	10 in 1 CARTON	TABLET, FILM COATED	10	37
63402-304-30	Latuda	30 in 1 BOTTLE	TABLET, FILM COATED	30	37
63402-304-50	Latuda	500 in 1 BOTTLE	TABLET, FILM COATED	500	37
63402-304-90	Latuda	90 in 1 BOTTLE	TABLET, FILM COATED	90	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63402-304-01	EA - Each	63402-304	f0e48d72-ae30-4c73-a204-b81ac9b644e5	1	2012-07-24
63402-304-10	EA - Each	63402-304	3736a131-fa85-46ff-a620-88269316cf9a	1	2012-07-24
63402-304-30	EA - Each	63402-304	12a13f84-47f5-4585-bb75-4230b5cdf849	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lurasidone hydrochloride	ACTIVE INGREDIENT	O0P4I5851I	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
lurasidone	ACTIVE MOIETY	22IC88528T	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
FD&C blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
hypromellose 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
mannitol	INACTIVE INGREDIENT	3OWL53L36A	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63402-304	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.]	36	Current NDC, Legacy NDC, 7 package rows	20250206_afad3051-9df2-4c54-9684-e8262a133af8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Latuda	LURASIDONE HYDROCHLORIDE	Sumitomo Pharma America, Inc.	afad3051-9df2-4c54-9684-e8262a133af8	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200603 application number: NDA200603 ndc (product): 63402-304

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
1297357	Latuda 120 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1235249	Latuda 20 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1040036	Latuda 40 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1431237	Latuda 60 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1040043	Latuda 80 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1297278	lurasidone HCl 120 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1235247	lurasidone HCl 20 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1040031	lurasidone HCl 40 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1431235	lurasidone HCl 60 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1040041	lurasidone HCl 80 MG Oral Tablet	PSN	afad3051-9df2-4c54-9684-e8262a133af8	37
1297357	lurasidone hydrochloride 120 MG Oral Tablet [Latuda]	SBD	afad3051-9df2-4c54-9684-e8262a133af8	37
1235249	lurasidone hydrochloride 20 MG Oral Tablet [Latuda]	SBD	afad3051-9df2-4c54-9684-e8262a133af8	37
1040036	lurasidone hydrochloride 40 MG Oral Tablet [Latuda]	SBD	afad3051-9df2-4c54-9684-e8262a133af8	37
1431237	lurasidone hydrochloride 60 MG Oral Tablet [Latuda]	SBD	afad3051-9df2-4c54-9684-e8262a133af8	37
1040043	lurasidone hydrochloride 80 MG Oral Tablet [Latuda]	SBD	afad3051-9df2-4c54-9684-e8262a133af8	37
1297278	lurasidone hydrochloride 120 MG Oral Tablet	SCD	afad3051-9df2-4c54-9684-e8262a133af8	37
1235247	lurasidone hydrochloride 20 MG Oral Tablet	SCD	afad3051-9df2-4c54-9684-e8262a133af8	37
1040031	lurasidone hydrochloride 40 MG Oral Tablet	SCD	afad3051-9df2-4c54-9684-e8262a133af8	37
1431235	lurasidone hydrochloride 60 MG Oral Tablet	SCD	afad3051-9df2-4c54-9684-e8262a133af8	37
1040041	lurasidone hydrochloride 80 MG Oral Tablet	SCD	afad3051-9df2-4c54-9684-e8262a133af8	37
1297357	Latuda 120 MG Oral Tablet	SY	afad3051-9df2-4c54-9684-e8262a133af8	37
1235249	Latuda 20 MG Oral Tablet	SY	afad3051-9df2-4c54-9684-e8262a133af8	37
1040036	Latuda 40 MG Oral Tablet	SY	afad3051-9df2-4c54-9684-e8262a133af8	37
1431237	Latuda 60 MG Oral Tablet	SY	afad3051-9df2-4c54-9684-e8262a133af8	37
1040043	Latuda 80 MG Oral Tablet	SY	afad3051-9df2-4c54-9684-e8262a133af8	37

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63402-304-01	63402030401	10 in 1 BLISTER PACK						Historical
63402-304-04	63402030404	4 BLISTER PACK in 1 CARTON (63402-304-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-304-07)	4 blister pack	2010-10-28	0000-00-00	No	No	Current
63402-304-07	63402030407	7 in 1 BLISTER PACK						Historical
63402-304-10	63402030410	10 BLISTER PACK in 1 CARTON (63402-304-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-304-01)	10 blister pack	2010-10-28	0000-00-00	No	No	Current
63402-304-30	63402030430	30 TABLET, FILM COATED in 1 BOTTLE (63402-304-30)		2010-10-28	0000-00-00	No	No	Current
63402-304-50	63402030450	500 TABLET, FILM COATED in 1 BOTTLE (63402-304-50)		2010-10-28	0000-00-00	No	No	Current
63402-304-90	63402030490	90 TABLET, FILM COATED in 1 BOTTLE (63402-304-90)		2010-10-28	0000-00-00	No	No	Current