Omeprazole

Product NDC
71335-9744
11-digit product format
713359744
Labeler code
71335
Product ID
71335-9744_53a718b7-c84e-4b00-887f-783f41226d91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091352
Marketing category
ANDA
Marketing start
2012-11-23
Substance
OMEPRAZOLE
Active strength
40 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
71335-9744-17133597440160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-1) 2023-07-10NoNoHistorical
71335-9744-27133597440230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-2) 2023-07-10NoNoHistorical
71335-9744-37133597440320 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-3) 2023-07-10NoNoHistorical
71335-9744-47133597440490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-4) 2023-07-10NoNoHistorical
71335-9744-57133597440514 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-5) 2023-07-10NoNoHistorical
71335-9744-671335974406120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-6) 2023-07-10NoNoHistorical
71335-9744-771335974407100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-7) 2023-07-10NoNoHistorical
71335-9744-871335974408180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9744-8) 2023-07-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OmeprazoleBryant Ranch Prepack2023-07-10HUMAN PRESCRIPTION DRUG LABEL100