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 6 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acid ReducerOMEPRAZOLE MAGNESIUMLEADER/ Cardinal Health 110, Inc.1dc00f13-d1f5-15a0-32cc-4fc041865e722025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMAlbertsons Companies302b1332-181b-834b-4154-d849cb3a1ef02025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Incdaeeba93-29d5-efb4-a591-3e72c4e503412025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESThe Kroger Co.8a6bbc31-7c50-a730-4233-e346fd7eb5ba2025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.fe0eb905-2042-aed1-a67d-a219e76f679b2025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMWalgreens Companyee8b1740-9bcf-5b70-bd8d-97f98303dc722025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESWal-Mart Stores Inc3160e212-9ee9-8316-f51e-4628862f654c2025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Consortium, LLC39ac65c0-d957-125f-f00b-e3846a4374892025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationfdf1259b-e9d3-70a9-c209-e2eb6b1528412025-07-22WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.f873dc20-c817-5e4f-e053-6394a90a04f22025-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Zegerid OTCOMEPRAOLE, SODIUM BICARBONATERiley Consumer Care LLC8d00c19a-d86b-4a2f-8791-b320ad3ca7812025-07-15WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLECardinal Health 107, LLCfbd71fd8-3f36-46a1-bc76-53f6820d42a22025-06-05Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
omeprazoleOMEPRAZOLEKroger Companyda18d91c-5fe9-44d4-9d6f-602900af3f082025-06-04WarningsExact identifier
unii: KG60484QX9
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited0e8fde83-a55c-edaf-3c66-e1fc77d0bc112025-05-28WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLESun Pharmaceutical Industries, Inc.51c3ef34-b7c1-419e-a784-ae82540c7a222025-04-28WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.0fb314cb-6291-422c-98ff-24d8449992f62025-04-23Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
careone omeprazoleOMEPRAZOLERetail Business Services, LLC063cfad8-3ca6-4b72-a4c9-512b8047bae32025-04-17WarningsExact identifier
unii: KG60484QX9
leader omeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leader19beab17-ca25-4be3-bada-20a2e9aa26b52025-04-16WarningsExact identifier
unii: KG60484QX9
rugby omeprazoleOMEPRAZOLERugby Laboratories61952807-f38d-4e7a-8646-a8ec85d7fb372025-04-15WarningsExact identifier
unii: KG60484QX9
careone omeprazoleOMEPRAZOLEAmerican Sales Companya5ec923a-dbc7-43e0-b3b8-f61dcaa6765d2025-04-14WarningsExact identifier
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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