esomeprazole magnesium

Product NDC
41250-727
11-digit product format
412500727
Labeler code
41250
Product ID
41250-727_c73a6fc4-f4f9-48c8-96a3-0985b1cd0347
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-03-17
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
41250-727-01esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE13
41250-727-01esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
41250-727-03esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE33
41250-727-03esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-727ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]3Current NDC, Legacy NDC, 4 package rows20240810_1dd30fec-15f4-44b2-a38f-e59ff4da206d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN1dd30fec-15f4-44b2-a38f-e59ff4da206d3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD1dd30fec-15f4-44b2-a38f-e59ff4da206d3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY1dd30fec-15f4-44b2-a38f-e59ff4da206d3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY1dd30fec-15f4-44b2-a38f-e59ff4da206d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-727-01412500727011 BOTTLE in 1 CARTON (41250-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-03-170000-00-00NoNoCurrent
41250-727-03412500727033 BOTTLE in 1 CARTON (41250-727-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-03-170000-00-00NoNoCurrent