FDA.reportPublic FDA data

NDC 80425-0169-01 - 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
80425-0169
Requested NDC
80425-0169-01
Package NDCs from labels
80425-0169-1, 80425-0169-2, 80425-0169-3, 80425-0169-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2026-03-13
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, LLC2026-03-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0169-1OmeprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
80425-0169-2OmeprazoleDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE608
80425-0169-3OmeprazoleDR4 in 1 BOTTLECAPSULE, DELAYED RELEASE48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0169OMEPRAZOLE DR (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_c8bf92c9-1bab-7985-e053-2995a90a0225.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0169-1EA - Each80425-01697da0197c-5994-4368-be4a-7e443b21c60c12023-06-06
80425-0169-2EA - Each80425-01696e3f550b-1bde-4323-aeda-9aec7741233912023-04-07
80425-0169-3EA - Each80425-0169bb829510-36bc-4151-a0d4-04d3929be60912026-04-20

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 9 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
24 hr omeprazoleOMEPRAZOLEMeijer, Inc.36adb053-3189-4c91-87dd-e122a2c8e8122025-01-14WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLECamber Pharmaceuticals, Inc.0c6e00a2-31e8-4e84-928d-80e69a5fc6342025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAvPAKf77efc97-2565-38ab-e053-6394a90aebda2025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsf226173f-4318-43e0-847a-8ea237e6b41d2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
omeprazoleOMEPRAZOLECVS Pharmacyfb3b1c3b-d486-4fa6-9ebf-ee1812ed25122025-01-06WarningsExact identifier
unii: KG60484QX9
TopCare OmeprazoleOMEPRAZOLETopco Associates LLC4d98665d-38db-4c08-8406-cc0e45f7ab7c2025-01-02WarningsExact identifier
unii: KG60484QX9
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85afda-6b0c-d657-e053-2a95a90afb4b2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
unii: KG60484QX9
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85e324-ef9f-196c-e053-2995a90a384e2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Omeprazole DROMEPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCb4cd8ed1-d9d3-5b57-e053-2995a90a9f3c2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLESandoz Inc516170d4-4913-4577-a2d2-f5c52d1e79c62024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLESandoz Inc5a09ce48-7139-4fc7-9b6e-439459c8e8662024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
up and up omeprazoleOMEPRAZOLETarget Corporationd664c45d-564a-4692-ae8f-8dd980ffcd872024-12-30WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEWalgreen Company30a893d2-198a-4184-81b4-02399324ff292024-12-20WarningsExact identifier
unii: KG60484QX9
Good Sense OmeprazoleOMEPRAZOLEL. Perrigo Company11dfbf6c-59bf-4a30-b627-f49ccd31c0d02024-12-19WarningsExact identifier
unii: KG60484QX9
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC548629d3-8d93-465d-b6ac-2a42bc0baebf2024-12-19WarningsExact identifier
unii: KG60484QX9
exchange select omeprazoleOMEPRAZOLEArmy & Air Force Exchange Service22b4492d-7afe-410f-97bf-57e4a57b1c272024-12-19WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Inc4b3b389d-a151-d851-cb05-64eb49979e5e2024-12-19WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions59d8be3f-ba13-4897-9ceb-f8ac6ccc16242024-12-16Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions487ff32f-943e-458b-b898-bd7b0290cc492024-12-16Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEQuality Care Products, LLC581d1c3d-457a-41f2-8db0-5b6219cdcb092024-12-16Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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