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 10 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEA-S Medication Solutionsc8f2e604-74fa-4205-b41f-32401e2dc59e2024-12-16Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack064b1418-0f42-4b18-9dee-cda40c5e1fca2024-12-11Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepackc311c1b9-8ec2-4ac0-baa2-a5063fba2d802024-12-11Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
Equate omeprazole delayed release acid reducerOMEPRAZOLEWal-Mart Stores Inc9a0f2d8a-eaad-403b-90c3-0fd275abe4dc2024-12-08WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEZydus Lifesciences Limited2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca22024-12-03Exact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LPee0598a1-0e5e-40ff-ad88-b0adfc533ca02024-12-01Warnings, Adverse reactionsExact identifier
rxcui: 199119
unii: KG60484QX9
Leader OmeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leaderb2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a2024-11-26WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEGERI-CARE PHARMACEUTICALS, CORP8a77aea7-912e-43a3-bce3-f666b9b9c9bc2024-11-22WarningsExact identifier
unii: KG60484QX9
foster and thrive omeprazoleOMEPRAZOLEStrategic Sourcing Services LLC51bcc19d-acfc-487b-870b-251c8953741f2024-11-20WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLERising Pharma Holdings, Inc.a1b1c61b-d4fe-433d-ad31-0b11758976fa2024-11-12Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEWalgreens Company5e2994fc-8f44-f6e4-71fe-44a215aa93a92024-11-10WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Incb377cb0b-14b2-04bb-f276-fd69a257f9ca2024-11-10WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1249c42d-6358-48b3-8fe0-10333c7f501d2024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
omeprazoleOMEPRAZOLEINNOVUS PHARMACEUTICALS, INC.7535a309-1a67-4f50-911b-7cf5703229312024-10-30WarningsExact identifier
unii: KG60484QX9
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEScieGen Pharmaceuticals, Inc.a107804e-b308-4e79-9447-07d93016f70f2024-10-24Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEBryant Ranch Prepack44349466-73ea-4053-8ff6-5b4b7372c9cd2024-10-03Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP03ac077f-3873-4087-96d0-89049161dea92024-10-01Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LP253451a6-02a9-4b27-aed7-f3dbc2e096822024-10-01Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEProficient Rx LPf0f61a89-700d-481d-9255-6f9a9afa70252024-10-01Warnings, Adverse reactionsExact identifier
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLECVS Pharmacy19b5b960-cc4d-42d0-8c8a-04a355a4db922024-09-13WarningsExact identifier
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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