Dexlansoprazole

Product NDC: 70518-4791
11-digit product format: 705184791
Labeler code: 70518
Product ID: 70518-4791_5f75cd44-059d-f57c-e063-6394a90a312c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexlansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202666
Marketing category: ANDA
Marketing start: 2026-11-04
Substance: DEXLANSOPRAZOLE
Active strength: 60 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202666-001	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-09-16
A202666-002	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202666-001	AB
A202666-002	AB

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 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202666-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202666-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-09-16	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202666-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202666-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202666-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202666-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202666-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202666-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202666-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202666-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202666-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202666-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202666-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202666-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202666-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202666-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202666-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202666-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202666-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202666-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202666-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202666-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202666-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202666-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202666-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202666-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202666-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202666-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202666-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202666-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202666-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202666-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202666-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202666-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202666-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202666-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202666-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202666-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202666-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202666-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202666-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202666-002	AB	1	`ea1830bbd6c7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Dexlansoprazole
Brand name suffix: delayed release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXLANSOPRAZOLE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UYE4T5I70X	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55c550b4-eb8b-4e69-9c09-fa5125a52e65	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	59e0c5d7-12e9-b5d7-e063-6394a90a7366	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202666 application number: ANDA202666
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	Golden State Medical Supply, Inc.	f799b9b6-ba79-f335-e053-6294a90aaa68	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202666 application number: ANDA202666
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	Bryant Ranch Prepack	dcfe880a-b96d-4a3c-aa21-3998d0bcfe9e	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202666 application number: ANDA202666
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	Upsher-Smith Laboratories, LLC	8dca4887-c75a-4021-8564-b704e9e1fa3e	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202666 application number: ANDA202666
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	Bryant Ranch Prepack	31d3d485-5f87-4405-b940-490fa4ccf9cc	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202666 application number: ANDA202666
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	A-S Medication Solutions	4f44e84f-6219-4445-a67d-df37d18b014d	2023-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202666 application number: ANDA202666

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	Sample	Exclude flag	Status
70518-4791-0	70518479100	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4791-0)	2026-11-04	No	No	Current