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 14 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline omeprazoleOMEPRAZOLEUnited Natural Foods, Inc. dba UNFI78743f3b-257e-49df-98cd-6cc0e1b4e3702023-08-16WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLESTRATEGIC SOURCING SERVICES LLC56380ccc-6fc2-4e1b-bd87-da24c9aa31cd2023-08-14WarningsExact identifier
unii: KG60484QX9
equaline omeprazoleOMEPRAZOLEUnited Natural Foods, Inc. dba UNFIb6c87a6a-253a-4455-9b7d-62f506da592e2023-08-02WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP13b379ef-7982-434d-9e6b-e01cd2b398d22023-08-01Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,c6b5f808-4a49-1303-9711-badb022ecd702023-07-19WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack39e3b45a-8e9b-49d6-976a-6668f4e276492023-07-10Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthStar Rx LLCc5af5f4b-17be-7245-b281-f27c878312422023-06-20Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEZydus Pharmaceuticals USA Inc.9c22ceb2-2c34-43c3-9a35-2589c90787412023-05-11Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLESandoz Ince4562da8-9d94-4417-9f80-c1ffd42472592023-04-30Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLELannett Company, Inc.92201fb1-4570-42db-8da3-3b8c0e291d322023-04-21Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
omeprazoleOMEPRAZOLEWalgreen Company87cee50d-4c1e-473d-9d70-b1622f84aee12023-03-17WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LPa53ea447-add5-4ed5-aa7e-975b13d90e752023-02-01Warnings, Adverse reactionsExact identifier
rxcui: 199119
unii: KG60484QX9
omeprazoleOMEPRAZOLETHE KROGER COMPANYf55cedc7-e0bc-4d30-af52-bfa881f6adde2023-01-06WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLETwin Med LLC346141b5-b49d-489a-84eb-18df8b9404602023-01-06WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEHARRIS TEETERc618964f-4b16-448e-851b-e6b2a816c6602022-12-27WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLECamber Consumer Care Inc9c856d3a-e38f-4006-a43a-ec1a9fa0f0572022-11-28WarningsExact identifier
unii: KG60484QX9
Omeprazole, Sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEGuardian Drug Companye5c6c2cf-fb3b-456a-a0a0-be396d6f83192022-11-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP9786b04f-f827-460b-91bc-c0ac967f95dd2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEStrategic Sourcing Servicesdfa91081-3917-4dfc-9789-76800f57bb312022-05-11WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP2d99b4fd-49b3-403d-96a4-0cceda85a95c2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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