Omeprazole

Product NDC
60760-833
11-digit product format
607600833
Labeler code
60760
Product ID
60760-833_1f95e7cb-483d-64f3-e063-6294a90a34c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
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
60760-833-306076008333030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-833-30) 2024-07-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OmeprazoleST. MARY'S MEDICAL PARK PHARMACY2024-08-13HUMAN PRESCRIPTION DRUG LABEL2