FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
24075-0700
11-digit product format
240750700
Labeler code
24075
Product ID
24075-0700_d9ab5d7a-8b48-abd7-e053-2995a90ac5af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CSPC Ouyi Pharmaceutical Co., Ltd.
Application
ANDA212949
Marketing category
ANDA
Marketing start
2020-05-04
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
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
2023-12-31
Current FDA listing
Historical FDA.report record

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24075-0700-12024-01-30C16284748780-11030e365-5653-111a-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)
24075-0700-32024-01-30C16284748780-11030e365-5653-111a-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
24075-0700-1Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10003
24075-0700-3Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24075-0700ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [CSPC OUYI PHARMACEUTICAL CO., LTD.]3Legacy NDC, 2 package rows20220308_dcc86a23-f9ac-4fdb-91c4-3458bd7382c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNdcc86a23-f9ac-4fdb-91c4-3458bd7382c33
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNdcc86a23-f9ac-4fdb-91c4-3458bd7382c33
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDdcc86a23-f9ac-4fdb-91c4-3458bd7382c33
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDdcc86a23-f9ac-4fdb-91c4-3458bd7382c33
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYdcc86a23-f9ac-4fdb-91c4-3458bd7382c33
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYdcc86a23-f9ac-4fdb-91c4-3458bd7382c33
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYdcc86a23-f9ac-4fdb-91c4-3458bd7382c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24075-0700-1240750700011000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24075-0700-1) 2020-05-040000-00-00NoNoCurrent
24075-0700-32407507000330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24075-0700-3) 2020-05-040000-00-00NoNoCurrent