Omeprazole

Product NDC
67296-2183
11-digit product format
672962183
Labeler code
67296
Product ID
67296-2183_44f5aafa-b7be-b398-e063-6394a90ab9f3
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA207891
Marketing category
ANDA
Marketing start
2019-06-01
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
67296-2183-8672962183082 BOTTLE in 1 CARTON (67296-2183-8) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2019-06-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Omeprazole Delayed-release Tablets, 20 mgRedpharm Drug2025-12-02HUMAN OTC DRUG LABEL1