Omeprazole

Product NDC
50090-6888
11-digit product format
500906888
Labeler code
50090
Product ID
50090-6888_bf0ee06f-ffce-4ac6-9680-2425f8f7a887
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211732
Marketing category
ANDA
Marketing start
2020-03-25
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
50090-6888-0500906888002 BOTTLE in 1 CARTON (50090-6888-0) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2023-12-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Omeprazole Delayed-Release Tablets, 20 mg/acid reducerA-S Medication Solutions2023-12-14HUMAN OTC DRUG LABEL1