careone esomeprazole magnesium

Product NDC
41520-727
11-digit product format
415200727
Labeler code
41520
Product ID
41520-727_96c2b7f1-ae2c-4b41-b58a-183b654a70ff
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
American Sales Company
Application
ANDA207193
Marketing category
ANDA
Marketing start
2017-09-26
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
41520-727-01415200727011 BOTTLE in 1 CARTON (41520-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2017-10-13NoNoHistorical
41520-727-03415200727033 BOTTLE in 1 CARTON (41520-727-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2017-09-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
American Sales Company Esomeprazole Magnesium Drug FactsAmerican Sales Company2025-11-03HUMAN OTC DRUG LABEL5
American Sales Company Esomeprazole Magnesium Drug FactsAmerican Sales Company2019-12-18HUMAN OTC DRUG LABEL4