FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
50090-3023
11-digit product format
500903023
Labeler code
50090
Product ID
50090-3023_16ea0249-f13e-40ee-a158-ebb217c79ce2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-12-10
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
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
50090-3023-02024-01-30C16284748780-11030e365-36ba-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)
50090-3023-12024-01-30C16284748780-11030e365-36ba-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
50090-3023-0Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3020
50090-3023-1Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3023-0EA - Each50090-3023cd5e1289-8246-426e-aac1-0b603455ee7612019-05-02
50090-3023-1EA - Each50090-3023d92ad674-79d7-4a5d-bc66-fd664f588ab412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3023ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]20Legacy NDC, 2 package rows20220821_2895ab66-f276-440a-abbf-1f4407155706.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2895ab66-f276-440a-abbf-1f440715570620
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2895ab66-f276-440a-abbf-1f440715570620
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2895ab66-f276-440a-abbf-1f440715570620
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2895ab66-f276-440a-abbf-1f440715570620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3023-05009030230030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3023-0) 2018-02-230000-00-00NoNoCurrent
50090-3023-15009030230190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3023-1) 2017-05-190000-00-00NoNoCurrent