FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
76420-904
11-digit product format
764200904
Labeler code
76420
Product ID
76420-904_2cbe433d-9180-e5aa-e063-6394a90a452d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA211977
Marketing category
ANDA
Marketing start
2020-06-02
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
76420-904-00Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10001
76420-904-01Esomeprazole Magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
76420-904-12Esomeprazole Magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201
76420-904-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
76420-904-60Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
76420-904-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-904ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [ASCLEMED USA, INC.]1Current NDC, 6 package rows20250130_2690dbe7-e559-4de8-9582-79b627af1964.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY2690dbe7-e559-4de8-9582-79b627af19641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-904-00764200904001000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-00) 2025-01-28NoNoHistorical
76420-904-0176420090401100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-01) 2025-01-28NoNoHistorical
76420-904-1276420090412120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-12) 2025-01-28NoNoHistorical
76420-904-307642009043030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-30) 2025-01-28NoNoHistorical
76420-904-607642009046060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-60) 2025-01-28NoNoHistorical
76420-904-907642009049090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-90) 2025-01-28NoNoHistorical