LANSOPRAZOLE

Product NDC: 72288-672
Requested package NDC: 72288-672-55
11-digit product format: 722880672
Labeler code: 72288
Product ID: 72288-672_118fc2cf-cc34-49cf-944a-da4f41b69601
Type: HUMAN OTC DRUG
Nonproprietary name: Lansoprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: Amazon.com Services LLC
Application: NDA208025
Marketing category: NDA
Marketing start: 2026-08-12
Substance: LANSOPRAZOLE
Active strength: 15 mg/1
Pharmacologic classes: Inhibition Gastric Acid Secretion [PE], 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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208025-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL			2016-06-07

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208025-001	11077055	2036-04-21		Drug product	2021-08-03
N208025-001	11986554	2036-04-21		Drug product	2024-05-21

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`a72a2bbeb626…`

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: LANSOPRAZOLE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LANSOPRAZOLE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K5C5T2QPG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351261	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
d0a7e6e0-9a76-4a5a-aed7-aa976a174c0e	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LANSOPRAZOLE	LANSOPRAZOLE	Amazon.com Services LLC	d0a7e6e0-9a76-4a5a-aed7-aa976a174c0e	2026-08-12	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (package): 72288-672-55 ndc (product): 72288-672 ndc11 (package): 72288067255
Lansoprazole	LANSOPRAZOLE	Walgreen Company	a72f92cc-db49-40ef-a249-6b7c50dc8ef2	2026-02-28	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
lansoprazole	LANSOPRAZOLE	Kroger Company	4c0684b5-5c18-4ed5-8185-8b5d51dce3a0	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
Lansoprazole	LANSOPRAZOLE	CVS Pharmacy	992a8f95-475c-4e57-90cc-9839c8678427	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
topcare Lansoprazole	LANSOPRAZOLE	Topco Associates LLC	ec5d6d5c-11e7-4932-a48f-fb72218ceccd	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
Good Sense Lansoprazole	LANSOPRAZOLE	L. Perrigo Company	d86585b7-e146-4f04-9016-412b16e06f55	2025-01-29	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	f39feec2-54fb-47d4-9b45-08f75e92117e	2025-01-24	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
equate lansoprazole	LANSOPRAZOLE	Wal-Mart Stores Inc	89b91d5f-008c-4e9d-83e0-23b673b9c469	2022-12-07	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K5C5T2QPG	LANSOPRAZOLE	103577-45-3	LANSOPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72288-672-55	72288067255	3 CARTON in 1 CARTON (72288-672-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	3 carton	2026-08-12	No	No	Current