Omeprazole

Product NDC
50090-5111
11-digit product format
500905111
Labeler code
50090
Product ID
50090-5111_7c806ac1-dabf-4f02-89ad-9b38610bafec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-5111-05009051110090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5111-0) 2020-07-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OmeprazoleA-S Medication Solutions2025-12-02HUMAN PRESCRIPTION DRUG LABEL6