Lansoprazole

Product NDC
69842-270
11-digit product format
698420270
Labeler code
69842
Product ID
69842-270_774d659e-46bf-2367-b2ca-4011e8b3f584
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS Health Corp
Application
ANDA202194
Marketing category
ANDA
Marketing start
2020-12-23
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69842-270DDiscontinued by firm2026-08-07
excluded packagepackage69842-27069842-270-14DDiscontinued by firm2026-08-07
excluded packagepackage69842-27069842-270-28DDiscontinued by firm2026-08-07
excluded packagepackage69842-27069842-270-42DDiscontinued 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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69842-270-14DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69842-270-28DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69842-270-42DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69842-270-14DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69842-270-28DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69842-270-42DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69842-270-28DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69842-270-42DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69842-270-14DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69842-270-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69842-270-42DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69842-270-14DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69842-270-28DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69842-270-42DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69842-270-14DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69842-270-28DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69842-270-42DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69842-270-14DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69842-270-28DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69842-270-42DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69842-270-14DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69842-270-28DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69842-270-42DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69842-270-14DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69842-270-28DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69842-270-42DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69842-270-14DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69842-270-28DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69842-270-42DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69842-270-14DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69842-270-28DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69842-270-42DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69842-270-14DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69842-270-28DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69842-270-42DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69842-270-14DDiscontinued by firm557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202194-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18

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 UTC2026-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-270LANSOPRAZOLE CAPSULE, DELAYED RELEASE [CVS HEALTH CORP]2Legacy NDC20231103_a021d351-94cc-99b5-50a4-f42e8c02e4db.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.4a701c0d-fef5-aa12-01e6-e3680a161a7d2026-07-21WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLERugby Laboratories, Incaa95216c-8985-d160-1743-ba168a35177f2026-07-17WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.a24acc0b-7770-1087-77bd-048259a5bf722026-07-15WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLELEADER/ Cardinal Health 110, Inc.486838cd-17ee-c2df-4e05-aa6106dd8fd82026-07-15WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Limited15e05eda-48aa-a4b7-4b8a-4ee1cf1101202026-07-09WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEAMERISOURCEBERGEN DRUG CORPORATIONaccb92e8-dd14-b87b-c20a-6c4803815bc22026-04-17WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEChain Drug Marketing Association74417c65-cccd-5a6a-0f96-0d8cb5a1592a2025-07-18WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEWalgreens company277093d5-cd0f-36ad-63d4-824a62d2a16c2025-07-18WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-270-14698420270141 BOTTLE in 1 CARTON (69842-270-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-12-230000-00-00NoNoCurrent
69842-270-28698420270282 BOTTLE in 1 CARTON (69842-270-28) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2020-12-230000-00-00NoNoCurrent
69842-270-42698420270423 BOTTLE in 1 CARTON (69842-270-42) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-12-230000-00-00NoNoCurrent