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 8 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care OmeprazoleOMEPRAZOLESafeway6361a492-782f-4608-a20f-1bd86afbd8642025-02-06WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEH E B5ceaec04-3ca3-4c7c-9184-51a42686a5952025-02-05WarningsExact identifier
unii: KG60484QX9
kirkland signature omeprazoleOMEPRAZOLECostco Wholesale Company48a44d0c-3502-430b-8b75-188a49d14da22025-02-05WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEMeijer Distribution Inc925399c7-dcbc-4546-9111-2a98a11ba5382025-02-05WarningsExact identifier
unii: KG60484QX9
topcare omeprazoleOMEPRAZOLETopco Associates LLC436c5ea1-c5ee-481f-803d-439f65873b1c2025-01-31WarningsExact identifier
unii: KG60484QX9
up and up omeprazoleOMEPRAZOLETarget Corporation8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c562025-01-31WarningsExact identifier
unii: KG60484QX9
DG health omperazoleOMEPRAZOLEDolgencorp Inc99fdfeed-6828-4bf6-bb81-cd29a4ec610b2025-01-31WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEH E B344b5548-e5c0-45bf-bc3f-73af50bd59132025-01-30WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLECoupler LLC2cdc6809-3b1b-046a-e063-6394a90ae02a2025-01-29Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
unii: KG60484QX9
Basic Care OmeprazoleOMEPRAZOLEAmazon.com Services LLC87a2aa9b-c681-41c7-8a59-b359efd443cb2025-01-22WarningsExact identifier
unii: KG60484QX9
good sense omeprazoleOMEPRAZOLEL. Perrigo Companydcd93796-8904-415d-a379-c4ea590cf5442025-01-22WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEWalgreen Company064f048c-eddd-4370-9ee4-706f9f00c8d22025-01-22WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.a806da8c-5f84-454d-966c-da1c48710f802025-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLECVS Pharmacy64a62f09-19a9-4281-a55d-451fd33711c12025-01-17WarningsExact identifier
unii: KG60484QX9
dg health omeprazoleOMEPRAZOLEDolgencorp Inc6d19783d-2856-4a86-9f5c-6cc26b4ca33e2025-01-17WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEChain Drug Marketing Association INC77d4f6c7-87ca-78bb-3310-2304a68f9f9b2025-01-17WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsd1e0c8fc-1f15-45a4-a80f-653a1dae5e562025-01-16Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
omeprazoleOMEPRAZOLEMeijer Distribution Inc4e849a58-ad34-4d6e-a065-d1e5a1ac82182025-01-16WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEH E B491e3710-9a15-4b07-ae22-923bd1152ecc2025-01-16WarningsExact identifier
unii: KG60484QX9
dg health omeprazoleOMEPRAZOLEDolgencorp Inc3c34fa4b-be9f-4aa6-ab6b-775b528a89492025-01-16WarningsExact identifier
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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