FDA.reportPublic FDA data

NDC 80425-0109-01 - Omeprazole DR

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0109
Requested NDC
80425-0109-01
Package NDCs from labels
80425-0109-1, 80425-0109-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omeprazole DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0109-1OmeprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0109OMEPRAZOLE DR (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 1 package rows20250101_b4cd8ed1-d9d3-5b57-e053-2995a90a9f3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0109-1EA - Each80425-0109165f6334-08d5-4519-9ecd-fe9c364a0cd612023-06-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLECHAIN DRUG MARKETING ASSOCIATION, INC.da09aac6-8fce-448b-98ba-1fc9bce420752024-04-17WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEPublix Super Markets Inc05fae639-ba68-4c05-8ca7-7c5cc2d505842024-04-16WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited72fb11b6-b08c-2f02-d82b-f60f523949032024-04-15Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
omeprazoleOMEPRAZOLE MAGNESIUMMeijer, Inc.0340ef94-d2b4-47af-a045-d0d0312939842024-03-29WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEKroger Company236a9447-23ec-44c7-a241-20f9ddc83ab82024-03-25WarningsExact identifier
unii: KG60484QX9
Good Sense OmeprazoleOMEPRAZOLEL. Perrigo Companydb333c49-2c3e-4ade-a202-7d4499205fc42024-03-24WarningsExact identifier
unii: KG60484QX9
members mark omeprazoleOMEPRAZOLESam's West Inc907e9974-46b8-4dae-be92-518c076cb98f2024-03-07WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEWalgreen Companyb7972f17-4a63-4d78-a181-01ea6d7d39632024-03-04WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEOHM LABORATORIES INC.35a95bec-51b9-465b-aa93-ad26afb87be82024-02-29WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions0ef8d55f-6cae-4b58-844b-968d8e5b8c242024-02-27Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions1c99e189-93c0-4461-82c2-4521e6c4d5142024-02-27Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
foster and thrive omeprazoleOMEPRAZOLEStrategic Sourcing Services LLC836efc63-b633-497c-ab56-76bb495bd7232024-02-20WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAurohealth LLC19097902-a5e6-423a-8569-31c569cd3cdb2024-02-19WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEA-S Medication Solutionsa656a059-2b1a-44b3-85f8-af278032b54c2024-01-04Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutionsa52842ac-ac9d-4344-9823-b8b2afb079032023-12-14WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEVALU MERCHANDISERS COMPANY7b2d41b6-3e36-4973-b5f6-adf9b828f40d2023-12-13WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions8f13fd38-dc73-4072-bdc9-9474704a41212023-11-22Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 200329
unii: KG60484QX9
omeprazole sodium bicarbonateOMEPRAZOLE SODIUM BICARBONATECipla USA Inc.9cdde58a-ae8a-451f-92cf-cab178e4ba922023-11-01Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Omeprazole/Sodium BicarbonateOMEPRAZOLEStrides Pharma Science Limitedcf6d293e-d70d-443e-8292-d693e93aab552023-09-21Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutionsb129fe93-c8a2-4ae8-ad1b-8f9ae5779b682023-09-10Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.