esomeprazole magnesium

Product NDC
79481-0411
11-digit product format
794810411
Labeler code
79481
Product ID
79481-0411_aee69f51-77b9-48c9-8de3-2aa42dc88125
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA207193
Marketing category
ANDA
Marketing start
2024-03-21
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
N3PA6559FTESOMEPRAZOLE119141-88-7ESOMEPRAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0411-07948104110014 CAPSULE, DELAYED RELEASE in 1 BOTTLE (79481-0411-0) 2024-03-21NoNoHistorical
79481-0411-1794810411013 BOTTLE in 1 CARTON (79481-0411-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2024-03-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meijer Distribution, Inc. Esomeprazole Magnesium Drug FactsMeijer, Inc.2024-03-25HUMAN OTC DRUG LABEL2