omeprazole

Product NDC
59640-047
11-digit product format
596400047
Labeler code
59640
Product ID
59640-047_5d5df90d-3535-4337-99d8-e7e0309b433e
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
H E B
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
59640-047-03596400047033 BOTTLE in 1 CARTON (59640-047-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (59640-047-01) 3 bottle2022-03-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HEB Omeprazole Drug FactsH E B2025-02-27HUMAN OTC DRUG LABEL3