FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
50090-3903
11-digit product format
500903903
Labeler code
50090
Product ID
50090-3903_96ee6f06-177e-4db9-a023-392b192594a9
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3903-02023-01-30C16284748780-1f386c649-e3a2-0266-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)
50090-3903-12023-01-30C16284748780-1f386c649-e3a2-0266-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
50090-3903-0Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS306
50090-3903-1Esomeprazole Magnesium90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3903ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210417_7688374a-a641-456c-bf47-e21315dee864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7688374a-a641-456c-bf47-e21315dee8646
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7688374a-a641-456c-bf47-e21315dee8646
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7688374a-a641-456c-bf47-e21315dee8646
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7688374a-a641-456c-bf47-e21315dee8646

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3903-05009039030030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3903-0) 2018-12-050000-00-00NoNoCurrent
50090-3903-15009039030190 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50090-3903-1) 2017-09-010000-00-00NoNoCurrent