esomeprazole magnesium

Product NDC
69842-703
11-digit product format
698420703
Labeler code
69842
Product ID
69842-703_7987a91c-0545-4606-a87e-5ece3aff596f
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-03-19
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
36H71644EQESOMEPRAZOLE MAGNESIUM DIHYDRATE217087-10-0ESOMEPRAZOLE MAGNESIUM DIHYDRATE
R6DXU4WAY9ESOMEPRAZOLE MAGNESIUM217087-09-7esomeprazole magnesium

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69842-703-01698420703011 BOTTLE in 1 CARTON (69842-703-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-03-19NoNoHistorical
69842-703-03698420703033 BOTTLE in 1 CARTON (69842-703-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-03-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CVS Pharmacy, Inc. Esomeprazole Magnesium Drug FactsCVS Pharmacy2024-08-06HUMAN OTC DRUG LABEL3