esomeprazole magnesium

Product NDC
37012-898
11-digit product format
370120898
Labeler code
37012
Product ID
37012-898_23de2065-4eb8-46df-ae26-3733f3563bdb
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-27
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE
Active strength
20 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37012-898DDiscontinued by firm2026-08-03
excluded packagepackage37012-89837012-898-01DDiscontinued by firm2026-08-03
excluded packagepackage37012-89837012-898-02DDiscontinued by firm2026-08-03
excluded packagepackage37012-89837012-898-03DDiscontinued by firm2026-08-03

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 · 48 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 packagepackage37012-898-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37012-898-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37012-898-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-898-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-898-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-898-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-898-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-898-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-898-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-898-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-898-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-898-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-898-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-898-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-898-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-898-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-898-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-898-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-898-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-898-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-898-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-898-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-898-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-898-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-898-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-898-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-898-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-898-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-898-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-898-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-898-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-898-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-898-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-898-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-898-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-898-02557ba5c1ecfa…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
A207193-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18

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 UTC2026-02A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18cb3db0bc1861…

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESOMEPRAZOLE MAGNESIUM MINISESOMEPRAZOLE MAGNESIUM DIHYDRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc1435a38-b816-45a1-a0f6-4ad0c5b6da582026-07-27WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLERite Aid Corporation6996642f-a63e-4be9-aefd-0634e9914c2b2026-07-07WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Basic Care Esomeprazole MagnesiumESOMEPRAZOLEAmazon.com Services LLC42dd2e93-776c-4f49-b590-afc7dab6ef2f2026-06-17WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companyf13088de-6841-453e-acb0-08bbdf9529d12026-05-20WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEHyVee Incc2308fc8-1549-476d-9769-2991051360ad2026-03-24WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
EQUATE ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLEWALMART INC.ce5f2915-327d-4a91-b7fd-e399664a250f2026-03-19WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Foster and Thrive Acid ReducerESOMEPRAZOLEStrategic Sourcing Services LLC32933772-c0ef-46ad-84e5-d70218bcc8662026-03-07WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEWalgreen Company29eb7b87-59a4-4d27-ad53-789da7fec4272026-02-28WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
members mark esomeprazole magnesiumESOMEPRAZOLESam's West Inc87913038-4b90-40a0-bce5-2d368bd5758c2026-02-07WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEHyVee Incb0968243-171e-428a-b692-740e0c05a0fc2026-01-29WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
equate esomeprazole magnesiumESOMEPRAZOLEWal-Mart Stores Incaaafc536-f846-4019-a629-b52b3f36e6822026-01-19WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
berkley and jensen heartburn treatmentESOMEPRAZOLEBJWC2369c948-d46f-4ace-bc51-47477631bc432026-01-19WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
careone esomeprazole magnesiumESOMEPRAZOLEAmerican Sales Company3f9a2747-8afd-4898-bbfb-5f379293137e2025-11-03WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Esomeprazole MagnesiumESOMEPRAZOLEPublix Super Markets Inc60554fd6-96d5-4e73-b676-332116caa8002025-09-29WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
equate esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEWALMART INC.2d40c4bf-5b66-420c-9f17-3f31edc40d1a2025-09-11WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Up and Up Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMTarget Corporationb3d3ad1d-96f8-4f72-ae66-f14940a628822025-06-02WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
leader esomeprazole magnesiumESOMEPRAZOLECardinal Health 110, LLC. dba Leaderc9472b82-d345-4531-bf07-bd55c94876ab2025-04-23WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLECVS Pharmacy6f1d75c1-3c0d-41c2-a625-1ee1bf642c322025-01-11WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
topcare esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMTopco Associates LLC86384845-0bea-490b-b04a-5770ef88b6392024-09-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Good Sense Esomeprazole MagnesiumESOMEPRAZOLEL. Perrigo Company4a89b4b5-5c42-44ee-98a9-e26a237aaef72024-08-27WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-898-01370120898011 BOTTLE in 1 CARTON (37012-898-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-270000-00-00NoNoCurrent
37012-898-02370120898022 BOTTLE in 1 CARTON (37012-898-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-09-270000-00-00NoNoCurrent
37012-898-03370120898033 BOTTLE in 1 CARTON (37012-898-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-270000-00-00NoNoCurrent