Esomeprazole magnesium

Product NDC
50090-4639
11-digit product format
500904639
Labeler code
50090
Product ID
50090-4639_572fedcd-f9c0-47c8-9803-0d8587672052
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021153
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-10-01
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
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4639-0Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
50090-4639-1Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4639ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210417_34c76aa2-3cfc-4ee9-b4ce-674c13cd7182.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN34c76aa2-3cfc-4ee9-b4ce-674c13cd71825
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD34c76aa2-3cfc-4ee9-b4ce-674c13cd71825
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY34c76aa2-3cfc-4ee9-b4ce-674c13cd71825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4639-05009046390030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4639-0) 2019-10-220000-00-00NoNoCurrent
50090-4639-15009046390190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4639-1) 2019-10-220000-00-00NoNoCurrent