Omeprazole

Product NDC
68071-2688
11-digit product format
680712688
Labeler code
68071
Product ID
68071-2688_de384c26-bae1-2adc-e053-2a95a90ad0fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
KG60484QX9OMEPRAZOLE73590-58-6OMEPRAZOLE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2688-36807126880330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2688-3) 2022-05-040000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OmeprazoleNuCare Pharmaceuticals,Inc.2022-05-04HUMAN PRESCRIPTION DRUG LABEL1