FDA.reportPublic FDA data

equaline esomeprazole magnesium

Product NDC
41163-539
11-digit product format
411630539
Labeler code
41163
Product ID
41163-539_9f65f71f-5d51-434d-babd-ad3e63d5f556
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Supervalu Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-25
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE
Active strength
20 mg/1
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
41163-539-012026-01-29C16284748780-149896155-bd0c-586f-e063-e6dba90add90SuperValu Inc. Esomeprazole Magnesium Drug Facts
41163-539-022026-01-29C16284748780-149896155-bd0c-586f-e063-e6dba90add90SuperValu Inc. Esomeprazole Magnesium Drug Facts
41163-539-032026-01-29C16284748780-149896155-bd0c-586f-e063-e6dba90add90SuperValu Inc. Esomeprazole Magnesium Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-539-01equaline esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
41163-539-01equaline esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE19
41163-539-02equaline esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE29
41163-539-02equaline esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
41163-539-03equaline esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE39
41163-539-03equaline esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-539EQUALINE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]9Legacy NDC, 6 package rows20240809_653be152-7629-41f5-a864-62803f6eadfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN653be152-7629-41f5-a864-62803f6eadfb9
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD653be152-7629-41f5-a864-62803f6eadfb9
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY653be152-7629-41f5-a864-62803f6eadfb9
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY653be152-7629-41f5-a864-62803f6eadfb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-539-01411630539011 BOTTLE in 1 CARTON (41163-539-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-250000-00-00NoNoCurrent
41163-539-02411630539022 BOTTLE in 1 CARTON (41163-539-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2018-03-060000-00-00NoNoCurrent
41163-539-03411630539033 BOTTLE in 1 CARTON (41163-539-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-02-280000-00-00NoNoCurrent