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 15 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEProficient Rx LP2fc5065c-5850-469b-b357-fa4df30a8f782022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
omeprazoleOMEPRAZOLERite Aidb1ba65d1-8f68-4bae-bb9d-776bba3483462022-03-03WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEXiromed, LLC38bd8e13-591e-f11b-7d8a-11717c56493c2022-02-15Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLE MAGNESIUMWalgreen Company537b9a46-ecc8-4537-9657-c9ff7821dd4b2021-12-03WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLECVS Pharamacy, Inc0769e47f-f8f1-4b1c-a8cc-7c8385c740702021-04-16WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC4b188d97-f1b3-468d-9818-b8333bf24b5a2020-12-17Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLE MAGNESIUMUP & UPac10cf46-1dcc-483a-83d6-2fcb9896cc192020-12-04WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEMeijer Distribution Inc.8f5f9bbb-48d2-4fb1-81a2-3cbf070ed5732020-12-03WarningsExact identifier
rxcui: 198051
Good Sense Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEL. Perrigo Companybcf32242-de17-4da1-b707-4ce26262eb782020-11-16WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEINNOVUS PHARMACEUTICALS, INC.ce5c9fdc-0c50-4315-8f11-e00c9810abd02020-08-06WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCa0dc4ffa-db18-4871-9d36-51d02e3b2bd92019-03-20Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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