Lansoprazole

Product NDC
68788-6389
11-digit product format
687886389
Labeler code
68788
Product ID
68788-6389_cca963ac-f12f-4544-98c5-df674146d2db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090331
Marketing category
ANDA
Marketing start
2016-05-20
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-6389DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-1DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-2DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-3DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-4DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-6DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-7DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-8DDiscontinued by firm2026-10-05
excluded packagepackage68788-638968788-6389-9DDiscontinued by firm2026-10-05

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 2 · 108 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6389-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6389-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-6389-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-6389-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-6389-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-6389-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6389-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6389-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6389-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6389-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-6389-8302b2466d912…e7b80fea0513…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090331-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23
A090331-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-2384e616aacf4f…
2026-09-14 22:38:342026-08A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-2384e616aacf4f…
2026-08-18 06:07:402026-07A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORAL2010-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090331-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090331-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-04-2374a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090331-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090331-002AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090331-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090331-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090331-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090331-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090331-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090331-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090331-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090331-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090331-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090331-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090331-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090331-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090331-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090331-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090331-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090331-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090331-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090331-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090331-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090331-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090331-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090331-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090331-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090331-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090331-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090331-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090331-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090331-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090331-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090331-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090331-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090331-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090331-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090331-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090331-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090331-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090331-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090331-002AB11c564ffb4f44…

Reported adverse events (FAERS/openFDA)#

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