Esomeprazole Magnesium

Product NDC
70000-0695
11-digit product format
700000695
Labeler code
70000
Product ID
70000-0695_90df7bbb-c55e-4a01-90b7-c118b65617a9
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA214473
Marketing category
ANDA
Marketing start
2024-06-27
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
70000-0695-1700000695011 BOTTLE in 1 CARTON (70000-0695-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2024-06-27NoNoHistorical
70000-0695-2700000695023 BOTTLE in 1 CARTON (70000-0695-2) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2024-06-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Esomeprazole Magnesium Delayed-Release Tablets 20 mg *Cardinal Health | Aurohealth LLC | Aurobindo Pharma Limited2024-06-27Human OTC Drug Label1