FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
51407-742
11-digit product format
514070742
Labeler code
51407
Product ID
51407-742_43ced1f1-2ac8-a3e6-e063-6294a90a73f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA209735
Marketing category
ANDA
Marketing start
2018-04-30
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, 606730

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
51407-742-10Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-742-10EA - Each51407-7426e5fb3b5-5c11-4e62-b0ab-5ac8ac80ab0512025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN43cf2754-3ec7-75f7-e063-6394a90adfeb1
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN43cf2754-3ec7-75f7-e063-6394a90adfeb1
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD43cf2754-3ec7-75f7-e063-6394a90adfeb1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD43cf2754-3ec7-75f7-e063-6394a90adfeb1
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY43cf2754-3ec7-75f7-e063-6394a90adfeb1
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY43cf2754-3ec7-75f7-e063-6394a90adfeb1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY43cf2754-3ec7-75f7-e063-6394a90adfeb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-742-10514070742101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-742-10) 2025-08-25NoNoCurrent