Dexilant

Product NDC: 55154-5154
Requested package NDC: 55154-5154-8
11-digit product format: 551545154
Labeler code: 55154
Product ID: 55154-5154_66419cc6-0f7f-478b-9767-c724cb589e77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexlansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Cardinal Health 107, LLC
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: 2023-12-31
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	55154-5154	55154-5154-8	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-5154	55154-5154-8	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-5154	55154-5154-8	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dexlansoprazole	ACTIVE INGREDIENT	UYE4T5I70X	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
dexlansoprazole	ACTIVE MOIETY	UYE4T5I70X	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)	INACTIVE INGREDIENT	5KY68S2577	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
polyethylene glycol 8000	INACTIVE INGREDIENT	Q662QK8M3B	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
potassium chloride	INACTIVE INGREDIENT	660YQ98I10	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
sucrose	INACTIVE INGREDIENT	C151H8M554	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3

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
55154-5154-8	55154515408	1800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55154-5154-8)	2010-04-12	0000-00-00	No	No	Current