FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
45865-892
11-digit product format
458650892
Labeler code
45865
Product ID
45865-892_7df002ca-e0b0-24fe-e053-2991aa0ab75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
medsourcer pharmaceuticals
Application
ANDA205606
Marketing category
ANDA
Marketing start
2016-04-21
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-892-302025-01-30C16284748780-12cef2736-a9dc-d83d-e063-dadaa90ab31fThese 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)
45865-892-602025-01-30C16284748780-12cef2736-a9dc-d83d-e063-dadaa90ab31fThese 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
45865-892-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
45865-892-60Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-892ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEDSOURCER PHARMACEUTICALS]2Legacy NDC, 2 package rows20181227_7df009b0-311a-3d49-e053-2991aa0a3c44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7df009b0-311a-3d49-e053-2991aa0a3c442
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7df009b0-311a-3d49-e053-2991aa0a3c442
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7df009b0-311a-3d49-e053-2991aa0a3c442
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7df009b0-311a-3d49-e053-2991aa0a3c442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-892-304586508923030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-892-30) 2018-06-010000-00-00NoNoCurrent
45865-892-604586508926060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-892-60) 2018-06-010000-00-00NoNoCurrent