FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
68788-8524
11-digit product format
687888524
Labeler code
68788
Product ID
68788-8524_efc27899-0425-4367-80ea-3045c6eb59f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213486
Marketing category
ANDA
Marketing start
2023-09-14
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Active strength
40 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 TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606730

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
68788-8524-1esomeprazole magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1003
68788-8524-2esomeprazole magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE203
68788-8524-3esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
68788-8524-6esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
68788-8524-9esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8524ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 5 package rows20250502_2d21ed0b-a089-46f4-9ebb-f24f9f3af61d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8524-168788852401100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-1) 2023-09-14NoNoHistorical
68788-8524-26878885240220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-2) 2023-09-14NoNoHistorical
68788-8524-36878885240330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-3) 2023-09-14NoNoHistorical
68788-8524-66878885240660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-6) 2023-09-14NoNoHistorical
68788-8524-96878885240990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-9) 2023-09-14NoNoHistorical