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 11 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLEPublix Super Markets Ince4a68b0a-a550-4416-8911-1defe014ad892024-09-09WarningsExact identifier
unii: KG60484QX9
basic care omeprazoleOMEPRAZOLE MAGNESIUMAmazon.com Services LLCa4627be3-9845-428d-b3b1-c3096ae3d9b42024-09-05WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEA-S Medication Solutions30e58465-c5d2-4925-85bb-53faa6135c5c2024-09-05Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP5ad413ed-a21b-4f8b-9322-8fbb813b14d32024-09-01Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
TopCare Omeprazole delayed releaseOMEPRAZOLETopco Associates LLC8ed57521-e69a-4563-9ce2-4f6d667f065d2024-08-30WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions1eb34cff-59c5-4411-b587-10207ffb58c42024-08-30Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLELiving Better Brands LLC1d500e2d-395b-437e-a95c-3922a71a09562024-08-12WarningsExact identifier
unii: KG60484QX9
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC73c36634-a70f-4641-910f-6cdda7fbcd362024-08-08WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutionsfe7d3352-d53f-4046-92ed-1eb5c917fbee2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions8d925ca6-83f1-4263-8218-4bf7cc8ceb392024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack2b7491dd-19f5-42e0-b901-7ba71a3820c72024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack17664f71-154a-47c6-b83c-b349bbc8a98f2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions9378c870-f2cc-4a60-b0fd-08a4d43857bc2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
topcare omeprazoleOMEPRAZOLETopco Associates LLCec9d8dab-480c-49bc-bdbb-bebcc7676d012024-08-06WarningsExact identifier
unii: KG60484QX9
up and up omeprazoleOMEPRAZOLETarget Corporation2f2b26fe-dbc2-4185-8a27-6b166dd49ba22024-07-26WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions9724601b-bb12-4eb2-bc2e-0532976bf5d12024-07-24Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
up and up omeprazoleOMEPRAZOLETarget Corporation7dc339da-e90b-452b-b25e-8d7f3aa8bc182024-07-20WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCarePharmaceuticals, Inc.4be616c4-1b9a-5654-e054-00144ff88e882024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.ad675ef6-5377-b9f2-e053-2995a90a06e92024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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