FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
57483-225
11-digit product format
574830225
Labeler code
57483
Product ID
57483-225_3d8224e0-9922-4d9b-89c0-280504788f3c
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
INNOVUS PHARMACEUTICALS, INC.
Application
ANDA209339
Marketing category
ANDA
Marketing start
2023-05-25
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
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
57483-225-42Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
57483-225-42Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-225ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [INNOVUS PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20240507_a32039b7-8475-4ec5-abaf-07f9aee3954b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNa32039b7-8475-4ec5-abaf-07f9aee3954b2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDa32039b7-8475-4ec5-abaf-07f9aee3954b2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYa32039b7-8475-4ec5-abaf-07f9aee3954b2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYa32039b7-8475-4ec5-abaf-07f9aee3954b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57483-225-42574830225423 BOTTLE in 1 CARTON (57483-225-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-05-25NoNoCurrent