FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
63941-971
11-digit product format
639410971
Labeler code
63941
Product ID
63941-971_b0af5ebe-d7b6-46ba-a461-d18f9294cf77
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Best Choice
Application
ANDA209339
Marketing category
ANDA
Marketing start
2017-10-16
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
63941-971-03Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE36
63941-971-03Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
63941-971-05Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE16
63941-971-05Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-971ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BEST CHOICE]6Current NDC, Legacy NDC, 4 package rows20240507_56120925-28e3-4e6c-b54d-490d7460984f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN56120925-28e3-4e6c-b54d-490d7460984f6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD56120925-28e3-4e6c-b54d-490d7460984f6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY56120925-28e3-4e6c-b54d-490d7460984f6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY56120925-28e3-4e6c-b54d-490d7460984f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-971-03639410971033 BOTTLE in 1 CARTON (63941-971-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-10-160000-00-00NoNoCurrent
63941-971-05639410971051 BOTTLE in 1 CARTON (63941-971-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-10-160000-00-00NoNoCurrent