Dexlansoprazole

Product NDC: 50090-7451
11-digit product format: 500907451
Labeler code: 50090
Product ID: 50090-7451_63e58a38-23a3-4331-a2b6-366d60a95e80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexlansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202294
Marketing category: ANDA
Marketing start: 2022-11-22
Substance: DEXLANSOPRAZOLE
Active strength: 60 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A202294-001	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2017-04-19
A202294-002	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2022-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202294-001	AB
A202294-002	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 · 75 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	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202294-002	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2022-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202294-001	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-04-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202294-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202294-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202294-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202294-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202294-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202294-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202294-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202294-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202294-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202294-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202294-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202294-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202294-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202294-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202294-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202294-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202294-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202294-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202294-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202294-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202294-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202294-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202294-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202294-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202294-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202294-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202294-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202294-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202294-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202294-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202294-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202294-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202294-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202294-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202294-002	AB	1	`a50c72e98297…`

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
Listing expiration: 2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
833213	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fc3de800-bfad-4e2f-b664-d58a67550b2f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
72065c97-63d2-e1f2-e507-59f0b1c78119	Product name	5	20250114

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7451-0	Dexlansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		3
50090-7451-1	Dexlansoprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7451-0	EA - Each	50090-7451	16f9c894-44c4-4094-ad0f-5ddedfe942f3	1	2024-12-10
50090-7451-1	EA - Each	50090-7451	ce9d1667-5cca-4cce-aaac-653f0e3ede84	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7451	DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]	3	Current NDC, 2 package rows	20241114_fc3de800-bfad-4e2f-b664-d58a67550b2f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexlansoprazole	DEXLANSOPRAZOLE	Par Health USA, LLC	d7452a26-db20-42fc-868a-a3e3606ca895	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294
Dexlansoprazole	DEXLANSOPRAZOLE	A-S Medication Solutions	fc3de800-bfad-4e2f-b664-d58a67550b2f	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294 ndc (product): 50090-7451
Dexlansoprazole	DEXLANSOPRAZOLE	Bryant Ranch Prepack	caad4ada-2cf9-4e12-99df-6ca4388cf0f6	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294
Dexlansoprazole	DEXLANSOPRAZOLE	Bryant Ranch Prepack	3ed69e5a-aa78-4118-aa32-59a10f80c901	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202294 application number: ANDA202294

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
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	PSN	fc3de800-bfad-4e2f-b664-d58a67550b2f	3
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	SCD	fc3de800-bfad-4e2f-b664-d58a67550b2f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7451-0	50090745100	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7451-0)	2024-11-11	No	No	Current
50090-7451-1	50090745101	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7451-1)	2024-11-11	No	No	Current