FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
71335-1368
11-digit product format
713351368
Labeler code
71335
Product ID
71335-1368_c5e7d732-9f76-42b8-895b-a06495045d18
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
20 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 DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
Rxcui606726

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
71335-1368-12024-05-20C16284748780-11030e365-032d-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)
71335-1368-22024-05-20C16284748780-11030e365-032d-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)
71335-1368-32024-05-20C16284748780-11030e365-032d-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)
71335-1368-42024-05-20C16284748780-11030e365-032d-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)
71335-1368-52024-05-20C16284748780-11030e365-032d-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)
71335-1368-62024-05-20C16284748780-11030e365-032d-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)
71335-1368-72024-05-20C16284748780-11030e365-032d-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)
71335-1368-82024-05-20C16284748780-11030e365-032d-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)
71335-1368-12024-01-30C16284748780-11030e365-032d-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)
71335-1368-22024-01-30C16284748780-11030e365-032d-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)
71335-1368-32024-01-30C16284748780-11030e365-032d-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)
71335-1368-42024-01-30C16284748780-11030e365-032d-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)
71335-1368-52024-01-30C16284748780-11030e365-032d-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)
71335-1368-62024-01-30C16284748780-11030e365-032d-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)
71335-1368-72024-01-30C16284748780-11030e365-032d-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)
71335-1368-82024-01-30C16284748780-11030e365-032d-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
71335-1368-1esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
71335-1368-2esomeprazole magnesium10 in 1 BOTTLECAPSULE, DELAYED RELEASE106
71335-1368-3esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
71335-1368-4esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906
71335-1368-5esomeprazole magnesium42 in 1 BOTTLECAPSULE, DELAYED RELEASE426
71335-1368-6esomeprazole magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE1206
71335-1368-7esomeprazole magnesium180 in 1 BOTTLECAPSULE, DELAYED RELEASE1806
71335-1368-8esomeprazole magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1368ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 8 package rows20240522_596e1cf8-dc6e-48b0-95ae-b463955870f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN596e1cf8-dc6e-48b0-95ae-b463955870f76
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD596e1cf8-dc6e-48b0-95ae-b463955870f76
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY596e1cf8-dc6e-48b0-95ae-b463955870f76
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY596e1cf8-dc6e-48b0-95ae-b463955870f76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1368-17133513680130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-1) 2019-10-150000-00-00NoNoCurrent
71335-1368-27133513680210 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-2) 2024-05-200000-00-00NoNoCurrent
71335-1368-37133513680360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-3) 2024-05-200000-00-00NoNoCurrent
71335-1368-47133513680490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-4) 2024-05-200000-00-00NoNoCurrent
71335-1368-57133513680542 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-5) 2024-05-200000-00-00NoNoCurrent
71335-1368-671335136806120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-6) 2024-05-200000-00-00NoNoCurrent
71335-1368-771335136807180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-7) 2024-05-200000-00-00NoNoCurrent
71335-1368-87133513680820 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-8) 2024-05-200000-00-00NoNoCurrent