Esomeprazole Magnesium

Product NDC
0363-3298
11-digit product format
003633298
Labeler code
0363
Product ID
0363-3298_097d5b7e-28cd-4b41-2d4c-d79d22921741
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Walgreens Company
Application
ANDA207673
Marketing category
ANDA
Marketing start
2018-12-31
Substance
ESOMEPRAZOLE MAGNESIUM
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
R6DXU4WAY9ESOMEPRAZOLE MAGNESIUM217087-09-7ESOMEPRAZOLE MAGNESIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-3298-01003633298013 BOTTLE in 1 CARTON (0363-3298-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2019-12-01NoNoHistorical
0363-3298-14003633298141 BOTTLE in 1 CARTON (0363-3298-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2018-12-31NoNoHistorical
0363-3298-28003633298282 BOTTLE in 1 CARTON (0363-3298-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2018-12-31NoNoHistorical
0363-3298-42003633298423 BOTTLE in 1 CARTON (0363-3298-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-12-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsWalgreens Company2025-10-28HUMAN OTC DRUG LABEL11
Drug FactsWalgreens Company2024-10-13HUMAN OTC DRUG LABEL10