Omeprazole

Product NDC
69842-661
11-digit product format
698420661
Labeler code
69842
Product ID
69842-661_20b6b69a-3bd9-42a4-a225-7efbf97a99eb
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
NDA022032
Marketing category
NDA
Marketing start
2022-03-28
Substance
OMEPRAZOLE
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
KG60484QX9OMEPRAZOLE73590-58-6OMEPRAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69842-661-01698420661011 BOTTLE in 1 CARTON (69842-661-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2022-03-28NoNoHistorical
69842-661-03698420661033 BOTTLE in 1 CARTON (69842-661-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2022-03-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CVS Pharmacy, Inc. Omeprazole Delayed Release Tablets 20 mg Drug FactsCVS Pharmacy2025-01-17HUMAN OTC DRUG LABEL4