FDA.reportPublic FDA data

Esomeprazole

Product NDC
57483-900
11-digit product format
574830900
Labeler code
57483
Product ID
57483-900_8f25bf5e-bf0d-413e-8f91-d3537939592b
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
INNOVUS PHARMACEUTICALS, INC.
Application
ANDA212866
Marketing category
ANDA
Marketing start
2020-08-14
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE20 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
57483-900-42Esomeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33
57483-900-42Esomeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-900ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [INNOVUS PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20241109_b3d10f0b-52af-408c-9b3d-f8f25f7c42bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb3d10f0b-52af-408c-9b3d-f8f25f7c42bd3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb3d10f0b-52af-408c-9b3d-f8f25f7c42bd3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb3d10f0b-52af-408c-9b3d-f8f25f7c42bd3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb3d10f0b-52af-408c-9b3d-f8f25f7c42bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57483-900-42574830900423 BOTTLE in 1 CARTON (57483-900-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-08-140000-00-00NoNoCurrent