equaline esomeprazole magnesium

Product NDC
41163-539
11-digit product format
411630539
Labeler code
41163
Product ID
41163-539_9f65f71f-5d51-434d-babd-ad3e63d5f556
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Supervalu Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-25
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct41163-539IInactivated by FDA2026-10-12
excluded packagepackage41163-53941163-539-01IInactivated by FDA2026-10-12
excluded packagepackage41163-53941163-539-02DDiscontinued by firm2026-10-12
excluded packagepackage41163-53941163-539-03DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0541163-539-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541163-539-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641163-539-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641163-539-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141163-539-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141163-539-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841163-539-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841163-539-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141163-539-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141163-539-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041163-539-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041163-539-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141163-539-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141163-539-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041163-539-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041163-539-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041163-539-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041163-539-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841163-539-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841163-539-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341163-539-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341163-539-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941163-539-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0941163-539-03557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-539-01equaline esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
41163-539-01equaline esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE19
41163-539-02equaline esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE29
41163-539-02equaline esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
41163-539-03equaline esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE39
41163-539-03equaline esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-539EQUALINE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]9Legacy NDC, 6 package rows20240809_653be152-7629-41f5-a864-62803f6eadfb.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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacydcaaf24a-0fb9-41b9-881a-00fa60796ca92024-08-06WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMMeijer Distribution Inc1dd30fec-15f4-44b2-a38f-e59ff4da206d2024-08-06WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
DG Health Esomeprazole MagnesiumESOMEPRAZOLEDolgencorp Inc2b0e555d-3ed5-4ec4-82a6-855351c503b32024-08-02WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp, LLC8f974698-ce9c-4ffb-b77e-9bad2c2ee2a12024-08-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
up and up esomeprazole magnesiumESOMEPRAZOLETarget Corporation717e5d5b-4bf7-415e-b259-44056bc96d8b2024-08-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
kirkland signature esomeprazole magnesiumESOMEPRAZOLECostco Wholesale Company4a87d5d5-c98b-4dc5-81be-50183342b0472024-08-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Good Neighbor Pharmacy Esomeprazole MagnesiumESOMEPRAZOLEAmerisource Bergenb596055c-98b2-47b1-b174-ae7ad3ba97ee2024-07-30WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Exchange Select Esomeprazole MagnesiumESOMEPRAZOLEArmy & Air Force Exchange Service5fa9089f-90d1-48b6-bb79-c6171eeeaa032024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
signature care esomeprazole magnesiumESOMEPRAZOLESafeway238b27e3-6993-4213-b7eb-062309398d1b2024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companye54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
signature care esomeprazole magnesiumESOMEPRAZOLESafeway972bb479-7146-454d-ace4-f9314f0e584e2024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
basic care esomeprazole magnesiumESOMEPRAZOLEAmazon.com Services LLC0b115351-318c-4bd9-935c-704a09bcdf522024-07-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEKroger Companyda02c079-ed18-4896-896d-0489c8f435542024-07-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEMeijer Distribution Inc126c269b-260d-40f4-879d-169c09251c672024-07-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp Incd5a842f3-d21b-4ddf-87f1-e44daf5cfe052024-05-08WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEMeijer, Inc.8799c88f-dafb-4be6-b279-a54d916162fe2024-03-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN653be152-7629-41f5-a864-62803f6eadfb9
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD653be152-7629-41f5-a864-62803f6eadfb9
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY653be152-7629-41f5-a864-62803f6eadfb9
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY653be152-7629-41f5-a864-62803f6eadfb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-539-01411630539011 BOTTLE in 1 CARTON (41163-539-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-250000-00-00NoNoCurrent
41163-539-02411630539022 BOTTLE in 1 CARTON (41163-539-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2018-03-060000-00-00NoNoCurrent
41163-539-03411630539033 BOTTLE in 1 CARTON (41163-539-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-02-280000-00-00NoNoCurrent