FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
21130-257
11-digit product format
211300257
Labeler code
21130
Product ID
21130-257_16821d33-b446-b089-e063-6294a90ab73f
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
BETTER LIVING BRANDS LLC.
Application
ANDA217264
Marketing category
ANDA
Marketing start
2024-04-29
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
21130-257-41Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-257-41Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32
21130-257-45Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
21130-257-45Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-257ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BETTER LIVING BRANDS LLC.]2Current NDC, 4 package rows20240429_f2c06861-0324-93ed-e053-2995a90a5902.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf2c06861-0324-93ed-e053-2995a90a59022
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf2c06861-0324-93ed-e053-2995a90a59022
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf2c06861-0324-93ed-e053-2995a90a59022
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf2c06861-0324-93ed-e053-2995a90a59022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-257-41211300257413 BOTTLE in 1 CARTON (21130-257-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2024-04-29NoNoHistorical
21130-257-45211300257451 BOTTLE in 1 CARTON (21130-257-45) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2024-04-29NoNoHistorical