basic care lansoprazole

Product NDC: 0113-7116
Requested package NDC: 0113-7116-55
11-digit product format: 001137116
Labeler code: 0113
Product ID: 0113-7116_9b09acc9-656c-4764-a2d1-5606f1e10e4d
Type: HUMAN OTC DRUG
Nonproprietary name: Lansoprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: L. Perrigo Company
Application: NDA208025
Marketing category: NDA
Marketing start: 2018-12-29
Marketing end: 0000-00-00
Substance: LANSOPRAZOLE
Active strength: 15 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0113-7116	0113-7116-55	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`053a50430f4f…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Marketing end	Sample	Exclude flag	Status
0113-7116-55	00113711655	3 CARTON in 1 CARTON (0113-7116-55) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	3 carton	2018-12-29	0000-00-00	No	No	Current