Dexlansoprazole

Product NDC: 0378-2085
11-digit product format: 003782085
Labeler code: 0378
Product ID: 0378-2085_bd08545b-3f1d-44c5-bdd9-05acd7f69a0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexlansoprazole
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA205205
Marketing category: ANDA
Marketing start: 2024-01-22
Substance: DEXLANSOPRAZOLE SESQUIHYDRATE
Active strength: 30 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 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
A205205-001	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2024-01-19
A205205-002	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2024-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205205-001	AB
A205205-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205205-001	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205205-002	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2024-01-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205205-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205205-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205205-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205205-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205205-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205205-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205205-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205205-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205205-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205205-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205205-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205205-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205205-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205205-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205205-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205205-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205205-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205205-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205205-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205205-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205205-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205205-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205205-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205205-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205205-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205205-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205205-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205205-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205205-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205205-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205205-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205205-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205205-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205205-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205205-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205205-002	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205205-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205205-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dexlansoprazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXLANSOPRAZOLE SESQUIHYDRATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HS2S9VK3NH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
833204	Internal RxNorm lookup
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
3f9699b5-7614-41cb-bd1d-ff02930e98f3	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-2085-05	Dexlansoprazole	500 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE PELLETS	500	2
0378-2085-77	Dexlansoprazole	90 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE PELLETS	90	2
0378-2085-93	Dexlansoprazole	30 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE PELLETS	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2085-93	EA - Each	0378-2085	4ee8023f-9ca3-4ffc-87c8-1551b60560c9	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2085	DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2	Current NDC, 3 package rows	20240510_3f9699b5-7614-41cb-bd1d-ff02930e98f3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexlansoprazole	DEXLANSOPRAZOLE	Mylan Pharmaceuticals Inc.	3f9699b5-7614-41cb-bd1d-ff02930e98f3	2023-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205205 application number: ANDA205205 ndc (product): 0378-2085

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HS2S9VK3NH	DEXLANSOPRAZOLE SESQUIHYDRATE	313640-86-7	DEXLANSOPRAZOLE SESQUIHYDRATE
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	3f9699b5-7614-41cb-bd1d-ff02930e98f3	2
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	PSN	3f9699b5-7614-41cb-bd1d-ff02930e98f3	2
833204	dexlansoprazole 30 MG Delayed Release Oral Capsule	SCD	3f9699b5-7614-41cb-bd1d-ff02930e98f3	2
833213	dexlansoprazole 60 MG Delayed Release Oral Capsule	SCD	3f9699b5-7614-41cb-bd1d-ff02930e98f3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0378-2085-05	00378208505	500 in 1 BOTTLE, PLASTIC				Historical
0378-2085-77	00378208577	90 in 1 BOTTLE, PLASTIC				Historical
0378-2085-93	00378208593	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93)	2024-01-22	No	No	Current