FDA.reportPublic FDA data

Up and Up Esomeprazole Magnesium

Product NDC
11673-753
11-digit product format
116730753
Labeler code
11673
Product ID
11673-753_b5be3ca8-b19c-4b5f-8018-ed6324482490
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-03-13
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
Up and Up 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
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
11673-753-01Up and Up Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
11673-753-01Up and Up Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE16
11673-753-03Up and Up Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE36
11673-753-03Up and Up Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-753UP AND UP ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]5Current NDC, Legacy NDC, 4 package rows20240810_b3d3ad1d-96f8-4f72-ae66-f14940a62882.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb3d3ad1d-96f8-4f72-ae66-f14940a628826
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb3d3ad1d-96f8-4f72-ae66-f14940a628826
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb3d3ad1d-96f8-4f72-ae66-f14940a628826
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb3d3ad1d-96f8-4f72-ae66-f14940a628826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-753-01116730753011 BOTTLE in 1 CARTON (11673-753-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-03-130000-00-00NoNoCurrent
11673-753-03116730753033 BOTTLE in 1 CARTON (11673-753-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-03-130000-00-00NoNoCurrent