Dexlansoprazole

Product NDC: 24979-704
Requested package NDC: 24979-704-06
11-digit product format: 249790704
Labeler code: 24979
Product ID: 24979-704_14535d19-cc1d-4a41-96f1-cc5ff1660029
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexlansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: TWI PHARMACEUTICALS, INC.
Application: NDA022287
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2022-01-01
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	24979-704	24979-704-06	I	Inactivated by FDA		2026-09-14

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
72065c97-63d2-e1f2-e507-59f0b1c78119	Product name	5	20250114
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24979-704-06	2026-01-29	C162847	48780-1	49896155-af37-586f-e063-e6dba90add90	These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)
24979-704-07	2026-01-29	C162847	48780-1	49896155-af37-586f-e063-e6dba90add90	These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24979-704-06	Dexlansoprazole delayed release	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		4
24979-704-07	Dexlansoprazole delayed release	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-704-06	EA - Each	24979-704	1864386b-71d2-41c2-b050-8cd1adfde36b	1	2022-02-07
24979-704-07	EA - Each	24979-704	e048f723-ca00-4665-ac09-576a93dc3c8a	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-704	DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TWI PHARMACEUTICALS, INC.]	4	Legacy NDC, 2 package rows	20230817_9abcfb1e-c894-44bb-807a-e4bdd755f28f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
833204	dexlansoprazole 30 MG Delayed Release Oral Capsule	PSN	9abcfb1e-c894-44bb-807a-e4bdd755f28f	4
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	PSN	7c7698da-3cda-4301-ae93-02fb64b9c90d	4
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	PSN	9abcfb1e-c894-44bb-807a-e4bdd755f28f	4
833204	dexlansoprazole 30 MG Delayed Release Oral Capsule	SCD	9abcfb1e-c894-44bb-807a-e4bdd755f28f	4
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	SCD	7c7698da-3cda-4301-ae93-02fb64b9c90d	4
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	SCD	9abcfb1e-c894-44bb-807a-e4bdd755f28f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24979-704-06	24979070406	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-704-06)	2022-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexlansoprazole delayed release	A-S Medication Solutions	2023-11-22	HUMAN PRESCRIPTION DRUG LABEL	4
Dexlansoprazole delayed release	TWI PHARMACEUTICALS, INC. \| Takeda Pharmaceutical Company Limited \| Abbvie Inc \| Catalent Pharma Solutions, LLC \| Takeda GmbH \| Takeda Ireland Limited \| Patheon Manufacturing Services LLC \| Anderson Brecon Inc \| F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.	2023-08-03	HUMAN PRESCRIPTION DRUG LABEL	4