National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:55:59

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63402-308-01	EA - Each	63402-308	e28b51f1-1ccf-4e42-9e49-26e48d7fa839	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63402-308	63402-308-01

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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	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 · 215 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
2026-09-14 22:38:34	2026-08	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 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	N200603-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200603-005	AB	1	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 85 · 3,385 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N200603-001	8729085	2026-05-26		Drug product	2014-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	8883794	2026-05-26		Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	9555027	2026-05-26	U-543	Drug product	2017-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	9907794	2026-05-26		Drug product	2018-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	8729085*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	8883794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	9907794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	9259423	2031-05-23	U-1822		2016-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	9827242	2031-05-23	U-2199		2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	9827242	2031-05-23	U-2201		2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-001	9259423*PED	2031-11-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	8729085	2026-05-26		Drug product	2014-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	8883794	2026-05-26		Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	9555027	2026-05-26	U-543	Drug product	2017-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	9907794	2026-05-26		Drug product	2018-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	8729085*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	8883794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	9907794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	9259423	2031-05-23	U-1822		2016-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	9827242	2031-05-23	U-2201		2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	9827242	2031-05-23	U-2199		2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-002	9259423*PED	2031-11-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	8729085	2026-05-26		Drug product	2014-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	8883794	2026-05-26		Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	9555027	2026-05-26	U-543	Drug product	2017-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	9907794	2026-05-26		Drug product	2018-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	8729085*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	8883794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	9907794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	9259423	2031-05-23	U-1822		2016-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	9827242	2031-05-23	U-2199		2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	9827242	2031-05-23	U-2201		2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-003	9259423*PED	2031-11-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	8729085	2026-05-26		Drug product	2014-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	8883794	2026-05-26		Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	9555027	2026-05-26	U-543	Drug product	2017-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	9907794	2026-05-26		Drug product	2018-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	8729085*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	8883794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200603-004	9907794*PED	2026-11-26		Pediatric extension		`84e616aacf4f…`

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…`

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 ndc (package): 63402-308-01 ndc11 (package): 63402030801

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.