FDA.reportPublic FDA data

dg health esomeprazole magnesium

Product NDC
55910-250
11-digit product format
559100250
Labeler code
55910
Product ID
55910-250_3924ab5d-59a4-41c0-9ff8-b03ac6dd317a
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-07-14
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
dg health 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
55910-250-01dg health esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
55910-250-01dg health esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE13
55910-250-02dg health esomeprazole magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE23
55910-250-02dg health esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
55910-250-03dg health esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE33
55910-250-03dg health esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-250DG HEALTH ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [DOLGENCORP, LLC]3Current NDC, Legacy NDC, 6 package rows20240810_8f974698-ce9c-4ffb-b77e-9bad2c2ee2a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN8f974698-ce9c-4ffb-b77e-9bad2c2ee2a13
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD8f974698-ce9c-4ffb-b77e-9bad2c2ee2a13
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY8f974698-ce9c-4ffb-b77e-9bad2c2ee2a13
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY8f974698-ce9c-4ffb-b77e-9bad2c2ee2a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-250-01559100250011 BOTTLE in 1 CARTON (55910-250-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-07-140000-00-00NoNoCurrent
55910-250-02559100250022 BOTTLE in 1 CARTON (55910-250-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2020-07-140000-00-00NoNoCurrent
55910-250-03559100250033 BOTTLE in 1 CARTON (55910-250-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2021-03-180000-00-00NoNoCurrent