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 5 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.cb657607-b038-47ee-b4e7-a5f419a14c332025-10-06Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals, Inc.28515ff8-379d-5356-e063-6394a90af3f32025-09-29Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEMajor Pharmaceuticalsafda9d2c-b141-4c32-a5b4-e850974b30a32025-09-19Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEMeijer Distribution Incbb7c1c5d-b915-42f5-a5a2-5f61b088028d2025-09-05WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3724b8f7-52ff-a5f8-e063-6294a90acf202025-09-02Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
unii: KG60484QX9
dg health omeprazoleOMEPRAZOLEDolgencorp, LLC326bf21c-fad4-473e-9e7f-797319d4353a2025-09-02WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3d6e07d1-38b1-f2ab-e063-6294a90a34ac2025-08-28Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCbab55f83-ba03-49a0-842a-19c9976b7fe82025-08-28Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e672025-08-26Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions5bda70ae-c3f6-450b-892f-6814795dd6ca2025-08-18Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEQuallent Pharmaceuticals Health LLC8090d4c3-3184-7812-53d7-aa30e14b79d12025-08-10Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.ded71262-d17f-3799-e053-2995a90a54272025-08-05Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2bf501-fd81-6ffa-e063-6394a90afe422025-07-30Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2cf6fd-72cb-fa53-e063-6394a90a674a2025-07-30Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPHOENIX RX LLC3b19d724-821b-61dc-e063-6294a90aa4d32025-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
unii: KG60484QX9
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMGericare Pharmaceuticals0e1f5d7c-5956-3be7-e054-00144ff8d46c2025-07-28WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMHEB5d8b3f5f-f680-64ae-b360-c0bd06b2ac922025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMCVS Health Corp.3bbfa87d-f8b7-19bd-9f12-39cba31ae0b32025-07-23WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEPHOENIX RX LLC3a9baece-03be-6c77-e063-6394a90a70322025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationab5d339b-2c02-611d-d5db-8e1891684fe02025-07-23WarningsExact identifier
rxcui: 198051

Reported adverse events (FAERS/openFDA)#

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