FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
71335-1335
11-digit product format
713351335
Labeler code
71335
Product ID
71335-1335_601fff53-da65-4454-8727-9f31affd84a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206296
Marketing category
ANDA
Marketing start
2019-05-30
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui606730

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1335-12024-05-20C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-22024-05-20C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-32024-05-20C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-42024-05-20C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-52024-05-20C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-62024-05-20C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-72024-05-20C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-12024-01-30C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-22024-01-30C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-32024-01-30C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-42024-01-30C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-52024-01-30C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-62024-01-30C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
71335-1335-72024-01-30C16284748780-11030e365-3509-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1335-1esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906
71335-1335-2esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
71335-1335-3esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
71335-1335-4esomeprazole magnesium10 in 1 BOTTLECAPSULE, DELAYED RELEASE106
71335-1335-5esomeprazole magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE206
71335-1335-6esomeprazole magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE1206
71335-1335-7esomeprazole magnesium180 in 1 BOTTLECAPSULE, DELAYED RELEASE1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1335ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 7 package rows20240522_925cee78-83af-480f-838d-8ba97ac6b1e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN925cee78-83af-480f-838d-8ba97ac6b1e36
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD925cee78-83af-480f-838d-8ba97ac6b1e36
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY925cee78-83af-480f-838d-8ba97ac6b1e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1335-17133513350190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-1) 2019-09-050000-00-00NoNoCurrent
71335-1335-27133513350230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-2) 2019-10-020000-00-00NoNoCurrent
71335-1335-37133513350360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-3) 2024-05-200000-00-00NoNoCurrent
71335-1335-47133513350410 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-4) 2024-05-200000-00-00NoNoCurrent
71335-1335-57133513350520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-5) 2024-05-200000-00-00NoNoCurrent
71335-1335-671335133506120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-6) 2024-05-200000-00-00NoNoCurrent
71335-1335-771335133507180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-7) 2024-05-200000-00-00NoNoCurrent