FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
50090-3846
11-digit product format
500903846
Labeler code
50090
Product ID
50090-3846_3e5841f0-1a24-4338-a990-7d1da8b6e340
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205563
Marketing category
ANDA
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
50090-3846-02023-01-30C16284748780-1f386c649-d2c1-0266-e053-dadaa90a7c1aThese 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)
50090-3846-12023-01-30C16284748780-1f386c649-d2c1-0266-e053-dadaa90a7c1aThese 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 USP, for oral use Initial U.S. Approval: 1989 (omeprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3846-0Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS303
50090-3846-1Esomeprazole Magnesium90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3846ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20190430_3bad56bb-f949-4db5-8e7f-50778458e1cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN3bad56bb-f949-4db5-8e7f-50778458e1cc3
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD3bad56bb-f949-4db5-8e7f-50778458e1cc3
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY3bad56bb-f949-4db5-8e7f-50778458e1cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3846-05009038460030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3846-0) 2018-11-190000-00-00NoNoCurrent
50090-3846-15009038460190 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50090-3846-1) 2017-09-010000-00-00NoNoCurrent