FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
11822-0024
11-digit product format
118220024
Labeler code
11822
Product ID
11822-0024_8fc50397-c8e2-4b2b-9fd6-8ad14f6a3fd6
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-06-26
Substance
ESOMEPRAZOLE
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
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
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
11822-0024-5esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
11822-0024-5esomeprazole magnesium1 in 1 CAPSULECAPSULE, DELAYED RELEASE13
11822-0024-7esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE33
11822-0024-7esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0024ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [RITE AID CORPORATION]3Current NDC, Legacy NDC, 4 package rows20240806_c55a4f7a-3b24-47e5-8ade-3b13df003301.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNc55a4f7a-3b24-47e5-8ade-3b13df0033013
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDc55a4f7a-3b24-47e5-8ade-3b13df0033013
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYc55a4f7a-3b24-47e5-8ade-3b13df0033013
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYc55a4f7a-3b24-47e5-8ade-3b13df0033013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0024-5118220024051 BOTTLE in 1 CAPSULE (11822-0024-5) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-07-010000-00-00NoNoCurrent
11822-0024-7118220024073 BOTTLE in 1 CARTON (11822-0024-7) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-06-260000-00-00NoNoCurrent