FDA.reportPublic FDA data

NDC 80425-0169-03 - 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
80425-0169-03
Package NDCs from labels
80425-0169-1, 80425-0169-2, 80425-0169-3, 80425-0169-03
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 1 of 15 · 300 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLERite Aid Corporation28a0b4c8-3ad3-451c-a957-28aef5e3d8b52026-09-09WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAmazon.com Services LLC94faa721-e925-4033-8661-d1990dfa920d2026-08-30WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.63b3982a-b541-4b0d-99d4-93a673e57d462026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: KG60484QX9
good now omeprazoleOMEPRAZOLEGobrands, Inc0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f2026-08-19WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEDiscount Drug Mart, Inc4d5f30c2-775d-a1a3-e063-6394a90a07ff2026-08-12WarningsExact identifier
unii: KG60484QX9
GoodMeds 24HR Acid Reducer Omeprazole 20mgOMEPRAZOLE 20MGCabinet Health P.B.C.58c9c8ef-b929-14eb-e063-6294a90a37612026-08-11WarningsExact identifier
unii: KG60484QX9
OMEPRAZOLEOMEPRAZOLEH E B4eb05eb3-be59-4132-95a8-5a8f5065d7582026-08-10WarningsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.ded0df8b-1813-4595-ac2b-5499704bfd482026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions6ea9a6f3-b756-4cdf-b3db-f666a2c17d662026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP062800b1-790a-41c3-a8be-94143d2c7fb62026-08-01Warnings, Adverse reactionsExact identifier
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.96104ea6-c08f-40b5-83f5-d840b317f1fd2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.0344268f-d8e6-48d5-b1e1-f750ed1d8a522026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
unii: KG60484QX9
careone omeprazoleOMEPRAZOLEAmerican Sales Company5b88717a-e90c-4e74-ae2a-29270e14a3cc2026-07-08WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLE MAGNESIUMYYBA CORP535c2543-84f3-f5c1-e063-6394a90adb1e2026-07-07WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy4c0cf466-f9e8-390e-e063-6294a90a2ed82026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEUnit Dose Solutions, Inc.557d4c2c-5541-3a51-e063-6394a90ad2782026-06-30Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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