Omeprazole

Product NDC
59726-740
11-digit product format
597260740
Labeler code
59726
Product ID
59726-740_d1b27e2d-8ea9-4871-bfa2-89463ae0dee0
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA206582
Marketing category
ANDA
Marketing start
2025-08-15
Substance
OMEPRAZOLE MAGNESIUM
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
426QFE7XLKOMEPRAZOLE MAGNESIUM95382-33-5OMEPRAZOLE MAGNESIUM
KG60484QX9OMEPRAZOLE73590-58-6Omeprazole

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59726-740-42597260740423 BOTTLE, PLASTIC in 1 BOX (59726-740-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2025-08-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETSP & L Development, LLC2025-08-08HUMAN OTC DRUG LABEL1