FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
41250-900
11-digit product format
412500900
Labeler code
41250
Product ID
41250-900_bda89e2d-5798-402f-9ddb-c8f4d7fc9140
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-22
Substance
ESOMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
esomeprazole magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
Rxcui606726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-900-01esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
41250-900-01esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15
41250-900-02esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE25
41250-900-02esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
41250-900-03esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE35
41250-900-03esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-900ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]5Current NDC, Legacy NDC, 6 package rows20240806_126c269b-260d-40f4-879d-169c09251c67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN126c269b-260d-40f4-879d-169c09251c675
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD126c269b-260d-40f4-879d-169c09251c675
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY126c269b-260d-40f4-879d-169c09251c675
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY126c269b-260d-40f4-879d-169c09251c675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-900-01412500900011 BOTTLE in 1 CARTON (41250-900-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-09-220000-00-00NoNoCurrent
41250-900-02412500900022 BOTTLE in 1 CARTON (41250-900-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2017-09-220000-00-00NoNoCurrent
41250-900-03412500900033 BOTTLE in 1 CARTON (41250-900-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-220000-00-00NoNoCurrent