Latuda

Product NDC: 70518-1936
Requested package NDC: 70518-1936-0
11-digit product format: 705181936
Labeler code: 70518
Product ID: 70518-1936_ba9db2b8-c058-59ce-e053-2995a90a2971
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lurasidone hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA200603
Marketing category: NDA
Marketing start: 2019-03-06
Marketing end: 0000-00-00
Substance: LURASIDONE HYDROCHLORIDE
Active strength: 120 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-1936	70518-1936-0	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-1936-0	2023-03-07	C162847	48780-1	f386c649-a299-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LATUDA safely and effectively. See full prescribing information for LATUDA. LATUDA (lurasidone hydrochloride) tablets, for oral use Initial U.S. Approval: 2010
70518-1936-0	2023-01-30	C162847	48780-1	f386c649-a299-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LATUDA safely and effectively. See full prescribing information for LATUDA. LATUDA (lurasidone hydrochloride) tablets, for oral use Initial U.S. Approval: 2010

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1936-0	70518193600	30 POUCH in 1 BOX, UNIT-DOSE (70518-1936-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-1936-1)	30 pouch	2019-03-06	0000-00-00	No	No	Current