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 12 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.6fa6afcf-33b3-3115-e053-2a91aa0abd0b2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.5564c9dc-6f99-6639-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.55a1fb3c-f040-2e39-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAdvanced Rx of Tennessee, LLC1d4ecc1e-5180-f75e-e063-6394a90a51a62024-07-15Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEMeijer Distribution Incd54e1097-bd56-4371-8e59-8ceab1a5e8242024-07-12WarningsExact identifier
unii: KG60484QX9
good sense omeprazole delayed releaseOMEPRAZOLEL. Perrigo Company38082e59-c509-4be5-b29c-33a97565df1c2024-06-27WarningsExact identifier
unii: KG60484QX9
members mark omeprazoleOMEPRAZOLESam's West Inc0edfa800-fb14-44dd-9c31-de930b864ef92024-06-25WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAurobindo Pharma Limited934601b6-fbba-43c4-a8ef-7a7dfe9f9a512024-06-17Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC76b941f0-a02f-43e8-821e-09ccf675d9442024-06-17WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.8991d464-7abc-4350-e053-2995a90a4ea72024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OMEPRAZOLEOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3e99b78b-7fb8-4514-a3db-58e59cd429d82024-06-13Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBoswell Pharmacy Services LLC d/b/a BPS Wholesale1ab3d84c-c563-6f04-e063-6394a90a34ff2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLE MAGNESIUMSafeway7ae4d70f-08f1-4586-965f-5a32fbe215912024-06-04WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEBryant Ranch Prepacke1f20429-cfaa-420b-a65a-271be37eb7992024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1318a1c1-222d-471a-92d6-3632c82fb9992024-05-24Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack18f5a7cc-40d8-4aeb-a601-47bc9024f1302024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
good neighbor pharmacy omeprazoleOMEPRAZOLEAmerisource Bergen5ee3cb79-5c0c-456f-b5d5-d5a008bbd1182024-04-26WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEApotex Corpb83329ac-a65e-b3af-a3fb-c5a6c740e5e72024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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