FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
45865-102
11-digit product format
458650102
Labeler code
45865
Product ID
45865-102_b77a9a86-1ec5-3647-e053-2a95a90a44b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA205563
Marketing category
ANDA
Marketing start
2020-07-03
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
2021-12-31
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
45865-102-302023-01-30C16284748780-1f386c649-cd12-0266-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)
45865-102-602023-01-30C16284748780-1f386c649-cd12-0266-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
45865-102-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS301
45865-102-60Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-102ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20201228_b77aa73a-3971-2570-e053-2995a90a908d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb77aa73a-3971-2570-e053-2995a90a908d1
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb77aa73a-3971-2570-e053-2995a90a908d1
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb77aa73a-3971-2570-e053-2995a90a908d1
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb77aa73a-3971-2570-e053-2995a90a908d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-102-304586501023030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-102-30) 2020-07-030000-00-00NoNoCurrent
45865-102-604586501026060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (45865-102-60) 2020-07-030000-00-00NoNoCurrent