FDA.reportPublic FDA data

members mark esomeprazole magnesium

Product NDC
68196-898
11-digit product format
681960898
Labeler code
68196
Product ID
68196-898_566fb836-800f-4bbc-baf0-5ae366d06d55
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA207193
Marketing category
ANDA
Marketing start
2019-12-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
members mark esomeprazole magnesium
Listing expiration
2027-12-31

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
68196-898-01members mark esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
68196-898-03members mark esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-898MEMBERS MARK ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [SAM'S WEST INC]5Current NDC, Legacy NDC, 2 package rows20241126_87913038-4b90-40a0-bce5-2d368bd5758c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN87913038-4b90-40a0-bce5-2d368bd5758c6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD87913038-4b90-40a0-bce5-2d368bd5758c6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY87913038-4b90-40a0-bce5-2d368bd5758c6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY87913038-4b90-40a0-bce5-2d368bd5758c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-898-016819608980114 in 1 BOTTLEHistorical
68196-898-03681960898033 BOTTLE in 1 CARTON (68196-898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-898-01) 3 bottle2019-12-260000-00-00NoNoCurrent