FDA.report

Omeprazole

Product NDC
51660-029
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES INC.
Application
ANDA207891
Marketing category
ANDA
Substance
OMEPRAZOLE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
51660-029-141 BOTTLE in 1 CARTON (51660-029-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE20190601NoHistorical
51660-029-272 BOTTLE in 1 CARTON (51660-029-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE20190601NoHistorical
51660-029-443 BOTTLE in 1 CARTON (51660-029-44) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE20190601NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
44f59d88-d401-950b-e063-6294a90a2a50Omeprazole Delayed-release Tablets, 20 mgRedpharm Drug2025-12-02HUMAN OTC DRUG LABEL1
35a95bec-51b9-465b-aa93-ad26afb87be8Omeprazole Delayed-release Tablets, 20 mgOHM LABORATORIES INC. | Sun Pharmaceutical Industries Limited2024-02-29HUMAN OTC DRUG LABEL8