FDA.reportPublic FDA data

equate esomeprazole magnesium

Product NDC
79903-293
11-digit product format
799030293
Labeler code
79903
Product ID
79903-293_500ecad2-edb3-4e4b-8bec-e7897a22dd17
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium dihydrate
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
WALMART INC.
Application
ANDA207193
Marketing category
ANDA
Marketing start
2025-02-07
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
equate esomeprazole magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii36H71644EQ
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
79903-293-14equate esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
79903-293-42equate esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-293EQUATE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) CAPSULE, DELAYED RELEASE [WALMART INC.]2Current NDC, 2 package rows20250228_2d40c4bf-5b66-420c-9f17-3f31edc40d1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2d40c4bf-5b66-420c-9f17-3f31edc40d1a3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2d40c4bf-5b66-420c-9f17-3f31edc40d1a3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2d40c4bf-5b66-420c-9f17-3f31edc40d1a3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2d40c4bf-5b66-420c-9f17-3f31edc40d1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-293-147990302931414 in 1 BOTTLEHistorical
79903-293-42799030293423 BOTTLE in 1 CARTON (79903-293-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (79903-293-14) 3 bottle2025-02-07NoNoCurrent