Lansoprazole

Product NDC
69842-507
11-digit product format
698420507
Labeler code
69842
Product ID
69842-507_8ce244ef-086e-4524-8cf8-9675eff19296
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
NDA208025
Marketing category
NDA
Marketing start
2017-12-02
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
2026-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-50769842-507-74DDiscontinued by firm2026-08-07

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208025-001LANSOPRAZOLELANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208025-001110770552036-04-21Drug product2021-08-03
N208025-001119865542036-04-21Drug product2024-05-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-073f01610625f2…
2019-09-15 20:21 UTC2019-09N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208025-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2016-06-07cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208025-001110770552036-04-21Drug product2021-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208025-001119865542036-04-21Drug product2024-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208025-001110770552036-04-21Drug product2021-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208025-001119865542036-04-21Drug product2024-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208025-001110770552036-04-21Drug product2021-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208025-001119865542036-04-21Drug product2024-05-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208025-001110770552036-04-21Drug product2021-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208025-001119865542036-04-21Drug product2024-05-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208025-001110770552036-04-21Drug product2021-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208025-001119865542036-04-21Drug product2024-05-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208025-001110770552036-04-21Drug product2021-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208025-001119865542036-04-21Drug product2024-05-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208025-001110770552036-04-21Drug product2021-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208025-001119865542036-04-21Drug product2024-05-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208025-001110770552036-04-21Drug product2021-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208025-001119865542036-04-21Drug product2024-05-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208025-001110770552036-04-21Drug product2021-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208025-001119865542036-04-21Drug product2024-05-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208025-001110770552036-04-21Drug product2021-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N208025-001119865542036-04-21Drug product2024-05-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208025-001110770552036-04-21Drug product2021-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208025-001119865542036-04-21Drug product2024-05-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208025-001110770552036-04-21Drug product2021-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208025-001119865542036-04-21Drug product2024-05-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208025-001110770552036-04-21Drug product2021-08-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208025-001119865542036-04-21Drug product2024-05-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208025-001110770552036-04-21Drug product2021-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208025-001110770552036-04-21Drug product2021-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208025-001110770552036-04-21Drug product2021-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208025-001110770552036-04-21Drug product2021-08-034b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N208025-001110770552036-04-21Drug product2021-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208025-001110770552036-04-21Drug product2021-08-03782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208025-001110770552036-04-21Drug product2021-08-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208025-001110770552036-04-21Drug product2021-08-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208025-001110770552036-04-21Drug product2021-08-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208025-001110770552036-04-21Drug product2021-08-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208025-001110770552036-04-21Drug product2021-08-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208025-001110770552036-04-21Drug product2021-08-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208025-001110770552036-04-21Drug product2021-08-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N208025-001110770552036-04-21Drug product2021-08-03053a50430f4f…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K5C5T2QPGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351261Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
992a8f95-475c-4e57-90cc-9839c8678427Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-507-55Lansoprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D36
69842-507-55Lansoprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D146
69842-507-74Lansoprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D146
69842-507-74Lansoprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-507LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [CVS PHARMACY]6Current NDC, Legacy NDC, 4 package rows20250221_992a8f95-475c-4e57-90cc-9839c8678427.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEWalgreen Companya72f92cc-db49-40ef-a249-6b7c50dc8ef22026-02-28WarningsExact identifier
application applno (NDA): 208025
application number: NDA208025
lansoprazoleLANSOPRAZOLEKroger Company4c0684b5-5c18-4ed5-8185-8b5d51dce3a02025-02-08WarningsExact identifier
application applno (NDA): 208025
application number: NDA208025
LansoprazoleLANSOPRAZOLECVS Pharmacy992a8f95-475c-4e57-90cc-9839c86784272025-02-08WarningsExact identifier
application applno (NDA): 208025
application number: NDA208025
ndc (product): 69842-507
topcare LansoprazoleLANSOPRAZOLETopco Associates LLCec5d6d5c-11e7-4932-a48f-fb72218ceccd2025-02-08WarningsExact identifier
application applno (NDA): 208025
application number: NDA208025
Good Sense LansoprazoleLANSOPRAZOLEL. Perrigo Companyd86585b7-e146-4f04-9016-412b16e06f552025-01-29WarningsExact identifier
application applno (NDA): 208025
application number: NDA208025
basic care lansoprazoleLANSOPRAZOLEAmazon.com Services LLCf39feec2-54fb-47d4-9b45-08f75e92117e2025-01-24WarningsExact identifier
application applno (NDA): 208025
application number: NDA208025
equate lansoprazoleLANSOPRAZOLEWal-Mart Stores Inc89b91d5f-008c-4e9d-83e0-23b673b9c4692022-12-07WarningsExact identifier
application applno (NDA): 208025
application number: NDA208025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN992a8f95-475c-4e57-90cc-9839c86784276
351261lansoprazole 15 MG Disintegrating Oral TabletSCD992a8f95-475c-4e57-90cc-9839c86784276
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY992a8f95-475c-4e57-90cc-9839c86784276

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-507-55698420507553 CARTON in 1 CARTON (69842-507-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2017-12-020000-00-00NoNoCurrent
69842-507-746984205077414 BLISTER PACK in 1 CARTON (69842-507-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2019-01-040000-00-00NoNoCurrent