FDA.reportPublic FDA data

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg

Product NDC
25000-075
11-digit product format
250000075
Labeler code
25000
Product ID
25000-075_2c8804c8-f28d-4381-ad8b-708009989b57
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium Delayed-Release Capsules, 20 mg
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA217264
Marketing category
ANDA
Marketing start
2023-09-30
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 Delayed-Release Capsules, 20 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 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
25000-075-76Esomeprazole Magnesium Delayed-Release Capsules, 20 mg14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
25000-075-76Esomeprazole Magnesium Delayed-Release Capsules, 20 mg1 in 1 CARTONCAPSULE, DELAYED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-075ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED]6Current NDC, 2 package rows20240319_32f26c74-3052-4a69-9dc7-d18f9d761a8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN32f26c74-3052-4a69-9dc7-d18f9d761a8b6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD32f26c74-3052-4a69-9dc7-d18f9d761a8b6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY32f26c74-3052-4a69-9dc7-d18f9d761a8b6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY32f26c74-3052-4a69-9dc7-d18f9d761a8b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25000-075-76250000075761 BOTTLE in 1 CARTON (25000-075-76) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2023-09-30NoNoCurrent