Dexilant

Product NDC: 50090-4374
Requested package NDC: 50090-4374-0
11-digit product format: 500904374
Labeler code: 50090
Product ID: 50090-4374_b5314019-ccda-448f-8681-1b2fb9db629d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexlansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA022287
Marketing category: NDA
Marketing start: 2010-04-12
Marketing end: 0000-00-00
Substance: DEXLANSOPRAZOLE
Active strength: 60 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
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	50090-4374	50090-4374-0	D	Discontinued by firm		2026-09-14

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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022287-001	DEXILANT	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30
N022287-002	DEXILANT	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022287-001	AB
N022287-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022287-001	8461187	2026-01-17		Drug product
N022287-001	9238029	2026-01-17		Drug product	2016-02-11
N022287-001	9011926	2026-02-24		Drug product	2015-05-01
N022287-001	8461187*PED	2026-07-17		Pediatric extension
N022287-001	7790755	2026-08-02		Drug product	2010-09-29
N022287-001	8105626	2026-09-27		Drug product	2012-02-28
N022287-001	7790755*PED	2027-02-02		Pediatric extension
N022287-001	8105626*PED	2027-03-27		Pediatric extension
N022287-001	8871273	2028-01-11		Drug product	2014-12-01
N022287-001	8173158	2030-03-17	U-949		2012-06-01
N022287-001	8173158	2030-03-17	U-950		2012-06-01
N022287-001	8173158	2030-03-17	U-951		2012-06-01
N022287-001	8173158*PED	2030-09-17		Pediatric extension
N022287-001	9233103	2032-03-05	U-1805		2016-02-11
N022287-002	8461187	2026-01-17		Drug product
N022287-002	9238029	2026-01-17		Drug product	2016-02-11
N022287-002	9011926	2026-02-24		Drug product	2015-05-01
N022287-002	8461187*PED	2026-07-17		Pediatric extension
N022287-002	7790755	2026-08-02		Drug product
N022287-002	8105626	2026-09-27		Drug product
N022287-002	7790755*PED	2027-02-02		Pediatric extension
N022287-002	8105626*PED	2027-03-27		Pediatric extension
N022287-002	8871273	2028-01-11		Drug product	2014-12-01
N022287-002	8173158	2030-03-17	U-949
N022287-002	8173158	2030-03-17	U-950
N022287-002	8173158	2030-03-17	U-951
N022287-002	8173158*PED	2030-09-17		Pediatric extension
N022287-002	9233103	2032-03-05	U-1805		2016-02-11

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 3 · 86 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	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 73 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	N022287-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022287-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022287-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022287-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022287-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022287-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022287-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022287-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022287-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022287-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022287-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022287-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022287-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022287-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022287-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022287-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022287-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022287-002	AB	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,908 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	N022287-001	8461187	2026-01-17		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	9238029	2026-01-17		Drug product	2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	9011926	2026-02-24		Drug product	2015-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8461187*PED	2026-07-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	7790755	2026-08-02		Drug product	2010-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8105626	2026-09-27		Drug product	2012-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	7790755*PED	2027-02-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8105626*PED	2027-03-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8871273	2028-01-11		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158	2030-03-17	U-951		2012-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158	2030-03-17	U-949		2012-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158	2030-03-17	U-950		2012-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158*PED	2030-09-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	9233103	2032-03-05	U-1805		2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8461187	2026-01-17		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	9238029	2026-01-17		Drug product	2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	9011926	2026-02-24		Drug product	2015-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8461187*PED	2026-07-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	7790755	2026-08-02		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8105626	2026-09-27		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	7790755*PED	2027-02-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8105626*PED	2027-03-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8871273	2028-01-11		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158	2030-03-17	U-951			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158	2030-03-17	U-950			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158	2030-03-17	U-949			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158*PED	2030-09-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	9233103	2032-03-05	U-1805		2016-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022287-001	8461187	2026-01-17		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	9238029	2026-01-17		Drug product	2016-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	9011926	2026-02-24		Drug product	2015-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8461187*PED	2026-07-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	7790755	2026-08-02		Drug product	2010-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8105626	2026-09-27		Drug product	2012-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	7790755*PED	2027-02-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8105626*PED	2027-03-27		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8871273	2028-01-11		Drug product	2014-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8173158	2030-03-17	U-951		2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8173158	2030-03-17	U-949		2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8173158	2030-03-17	U-950		2012-06-01	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022287-001	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-001	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-001	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022287-001	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-001	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-001	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-002	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-002	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-002	NPP	2019-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022287-001	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-001	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-001	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-002	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-002	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-002	NPP	2019-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022287-001	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-001	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-001	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-002	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-002	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-002	NPP	2019-07-08	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4374-0	2023-02-07	C162847	48780-1	f386c64a-3d3d-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DEXILANT safely and effectively. See full prescribing information for DEXILANT. DEXILANT (dexlansoprazole) delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)
50090-4374-0	2023-01-30	C162847	48780-1	f386c64a-3d3d-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DEXILANT safely and effectively. See full prescribing information for DEXILANT. DEXILANT (dexlansoprazole) delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4374-0	EA - Each	50090-4374	f4c12bba-51bf-414e-ab1f-a078318b2e4e	1	2022-07-06

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexilant	DEXLANSOPRAZOLE	Takeda Pharmaceuticals America, Inc.	9819f033-3bbe-442e-8e92-45fec77b237d	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022287 application number: NDA022287
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	A-S Medication Solutions	7c7698da-3cda-4301-ae93-02fb64b9c90d	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022287 application number: NDA022287

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UYE4T5I70X	DEXLANSOPRAZOLE	138530-94-6	DEXLANSOPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4374-0	50090437400	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4374-0)	2019-06-20	0000-00-00	No	No	Current