FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
53041-666
11-digit product format
530410666
Labeler code
53041
Product ID
53041-666_2bf79146-3c41-4704-9100-035b049ee79e
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Guardian Drug Company
Application
ANDA216149
Marketing category
ANDA
Marketing start
2023-03-24
Substance
ESOMEPRAZOLE MAGNESIUM
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
ESOMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-666-07Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
53041-666-07Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-666ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [GUARDIAN DRUG COMPANY]5Current NDC, 2 package rows20241220_8d6c552c-16d9-4e0e-ba1a-04dce8052f95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN8d6c552c-16d9-4e0e-ba1a-04dce8052f955
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD8d6c552c-16d9-4e0e-ba1a-04dce8052f955
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY8d6c552c-16d9-4e0e-ba1a-04dce8052f955
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY8d6c552c-16d9-4e0e-ba1a-04dce8052f955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53041-666-07530410666071 BOTTLE in 1 CARTON (53041-666-07) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2023-03-24NoNoHistorical