Esomeprazole magnesium

Product NDC
50090-5365
11-digit product format
500905365
Labeler code
50090
Product ID
50090-5365_d37316e4-ad82-48bd-963f-c7cebbc9ba6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209735
Marketing category
ANDA
Marketing start
2018-05-31
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 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
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
50090-5365-0Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
50090-5365-1Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5365ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_6fd71c88-021d-44dd-a6da-80a17461257e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN6fd71c88-021d-44dd-a6da-80a17461257e3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD6fd71c88-021d-44dd-a6da-80a17461257e3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY6fd71c88-021d-44dd-a6da-80a17461257e3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY6fd71c88-021d-44dd-a6da-80a17461257e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5365-05009053650030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5365-0) 2020-11-170000-00-00NoNoCurrent
50090-5365-15009053650190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5365-1) 2020-11-170000-00-00NoNoCurrent