Omeprazole

Product NDC
72559-010
11-digit product format
725590010
Labeler code
72559
Product ID
72559-010_e4a9ed33-1893-6101-e053-2a95a90ad383
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Little Pharma, Inc.
Application
ANDA210593
Marketing category
ANDA
Marketing start
2020-12-19
Marketing end
0000-00-00
Substance
OMEPRAZOLE MAGNESIUM
Active strength
21 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72559-010-06725590010063 BOTTLE in 1 CARTON (72559-010-06) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-12-190000-00-00NoNoCurrent