Omeprazole

Product NDC
41250-349
11-digit product format
412500349
Labeler code
41250
Product ID
41250-349_e3d7b200-cb51-46f2-aebf-b95ddac1b664
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
NDA209400
Marketing category
NDA
Marketing start
2018-03-13
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
41250-349-55412500349553 CARTON in 1 CARTON (41250-349-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-03-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meijer Distribution, Inc. Omeprazole Delayed Release Orally Disintegrating Tablets, 20 mg Drug FactsMeijer Distribution Inc2024-07-12HUMAN OTC DRUG LABEL4