FDA.reportPublic FDA data

NDC 80425-0071-01 - 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
80425-0071
Requested NDC
80425-0071-01
Package NDCs from labels
80425-0071-3, 80425-0071-2, 80425-0071-1, 80425-0071-01
Manufacturer
Advanced Rx 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 of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0071-1OmeprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE309
80425-0071-2OmeprazoleDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE609
80425-0071-3OmeprazoleDR120 in 1 BOTTLECAPSULE, DELAYED RELEASE1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0071OMEPRAZOLE DR (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250108_af85e324-ef9f-196c-e053-2995a90a384e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0071-1EA - Each80425-00714d54795a-131a-485d-85c4-dd4738c2028c12023-04-07
80425-0071-2EA - Each80425-007181d3a7ee-0a1a-48c6-a31d-8da35638475212023-04-07
80425-0071-3EA - Each80425-00718820d579-6cc6-4d02-ac40-68b408fcb38e12023-04-07

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 4 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zegerid OTCOMEPRAZOLE, SODIUM BICARBONATERiley Consumer Care LLC1d764fc5-8eae-4fc9-a2e9-3f1954a3ac052025-12-24WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEChartwell RX, LLC10f5502a-2e63-4f2a-a3ba-ddc5bd4030512025-12-22Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
good neighbor pharmacy omeprazoleOMEPRAZOLEAmerisource Bergenf9aab207-d309-49b5-b941-c2912b1865832025-12-21WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAmerican Health Packaging205652e1-7fbc-4b6a-bbd6-2fd346d812df2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
omeprazoleOMEPRAZOLEKroger Company015b1c8f-9d5b-4afc-a55c-1a731b5fc72a2025-12-08WarningsExact identifier
unii: KG60484QX9
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dd5d63-1376-1ff7-e053-2a95a90a1d942025-12-03Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLERedpharm Drug44f59d88-d401-950b-e063-6294a90a2a502025-12-02WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions17ccdbe0-19c1-498d-8e81-578be549b4e52025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dcf0b2-4fa2-023a-e053-2995a90a183a2025-12-01Warnings, Adverse reactionsExact identifier
application number: ANDA075576
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.bd84ca00-6352-4cb3-bce2-05f4a5005a942025-11-30Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEQuallent Pharmaceuticals Health LLC665e9877-85ac-fdb6-54ac-1c47941ceab82025-11-28Warnings, Adverse reactionsExact identifier
application number: ANDA075576
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC43090803-37de-77e3-e063-6294a90a8c432025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWalgreen Company8753a131-f8b1-48e1-993b-73c1ee635fef2025-11-04WarningsExact identifier
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATECVS Pharmacy186732a3-13b9-4ea2-ba54-424f63298a2e2025-11-04WarningsExact identifier
unii: KG60484QX9
basic care omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLC4587f491-04ef-4c31-b7b6-bfafd31776fb2025-11-04WarningsExact identifier
unii: KG60484QX9
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEH E Bddc8d73f-f4a1-42a7-89ee-420346820f612025-11-03WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.e235ef89-3592-4ca1-8c13-d7ce84b1001c2025-10-16Warnings, Adverse reactionsExact identifier
application number: ANDA075576
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutions530a8a66-48ad-474f-b170-c6fac95753ec2025-10-10Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.ed9895ae-3d18-434c-8b56-47bccdc8fe6d2025-10-08Warnings, Adverse reactionsExact identifier
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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