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 2 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacydb9f071b-85f4-061f-e053-2995a90a3ff52026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.d9b3918c-a66e-4277-8b8f-b7ece93fa7db2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy1eb57c13-25ed-70bc-e063-6294a90afdac2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEQPharma Inc50115204-74f7-17c1-e063-6394a90ab6652026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Berkley and Jensen OmeprazoleOMEPRAZOLEBJWCf74752a8-a686-4c7d-91ad-8c87c4596a7a2026-05-21WarningsExact identifier
unii: KG60484QX9
OMEPRAZOLEOMEPRAZOLESafewayb3ec4a44-5643-4438-b41b-e049464367192026-05-18WarningsExact identifier
rxcui: 198051
omeprazoleOMEPRAZOLEAmazon.com Services LLC7e0d319c-6917-45c4-b7e1-e870fc3fcea52026-05-13WarningsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEQPharma Incf6f6ad19-ff6a-7cd3-e053-6294a90ae1bf2026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPreferred Phharmaceuticals Inc.319d990e-161b-4c16-b026-f55c413c7e8f2026-04-21Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAMERISOURCEBERGEN DRUG CORPORATION0521c51b-d113-7e35-f1a6-c4495a2bcfcc2026-04-17WarningsExact identifier
unii: KG60484QX9
care one omeprazoleOMEPRAZOLEAmerican Sales Companydb2d75ea-5924-4b7f-a92d-d4847a010d522026-04-17WarningsExact identifier
unii: KG60484QX9
OMEPRAZOLEOMEPRAZOLEGolden State Medical Supply, Inc.f27b3518-d5c1-1229-e053-2a95a90ab56f2026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEST. MARY'S MEDICAL PARK PHARMACY4f5c91e6-6377-ca94-e063-6294a90a2f992026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP61eab342-61fd-471f-8f70-95f9cbca00972026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 199119
unii: KG60484QX9
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OMEPRAZOLEOMEPRAZOLECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6479415a-ffb0-4d20-ad00-f091c8aaaadb2026-03-31WarningsExact identifier
rxcui: 198051
OMEPRAZOLEOMEPRAZOLEWalgreen Company97eaf0dc-380b-4039-aeb7-dde39942a9d62026-03-31WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEWalmart Inc.5168ccd9-31b4-3a49-85b9-4f202cd99f6b2026-03-19WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutionsc1276463-7357-45b5-9f7e-8d3c4a550ff42026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutionsdf1a4294-3893-4a11-b4d5-f3536678087e2026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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