FDA.reportPublic FDA data

NDC 80425-0070-01 - 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
80425-0070
Requested NDC
80425-0070-01
Package NDCs from labels
80425-0070-4, 80425-0070-2, 80425-0070-1, 80425-0070-3, 80425-0070-01
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
80425-0070-1OmeprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE3010
80425-0070-2OmeprazoleDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE6010
80425-0070-3OmeprazoleDR120 in 1 BOTTLECAPSULE, DELAYED RELEASE12010
80425-0070-4OmeprazoleDR90 in 1 BOTTLECAPSULE, DELAYED RELEASE9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0070OMEPRAZOLE DR (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]10Current NDC, Legacy NDC, 4 package rows20250101_af85afda-6b0c-d657-e053-2a95a90afb4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0070-1EA - Each80425-0070de999aea-053c-402f-8bd1-c27394d5cbac12023-04-07
80425-0070-2EA - Each80425-007083bc1f74-abef-404a-8414-af04e1f114e612023-04-07
80425-0070-3EA - Each80425-0070abff5fed-28c7-4cb1-aa58-026660ed6c5f12023-08-08
80425-0070-4EA - Each80425-0070903e11fd-65db-46f5-a3a4-7912f21e404912023-04-07

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 3 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLELittle Pharma, Inc.d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f2026-03-16WarningsExact identifier
unii: KG60484QX9
equate omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWALMART INC.c24c3326-99da-4c7d-aecc-7b4a8ac3f04e2026-03-15WarningsExact identifier
unii: KG60484QX9
Omeprazole DROMEPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCc8bf92c9-1bab-7985-e053-2995a90a02252026-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.af707c0a-5193-3f83-e053-2995a90a78ef2026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.e07af8c9-559c-5a93-e053-2a95a90a2c632026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
omeprazoleOMEPRAZOLEMeijer, Inc.47c41c68-cb20-40f0-9d85-ea8db33284782026-03-06WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited603d2d06-c5e8-4378-a422-8dca1a410af72026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthStar Rx LLC40a75dc7-49b7-5c9d-6c5f-d4682ec6922e2026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
omeprazoleOMEPRAZOLEHyVee Inca5df7dac-00f4-4d97-9586-cde3055890ac2026-02-04WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEHyVee Incfd22d4df-9679-4c2d-9bc4-3619288fb4cc2026-02-01WarningsExact identifier
unii: KG60484QX9
omeprazoleOMEPRAZOLEHyVee Inccf9919e6-a839-4bad-a007-80d5bf6f81db2026-01-30WarningsExact identifier
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.288bdd5e-a0ac-4c5c-abe0-93183a28dcdd2026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEGlenmark Pharmaceuticals Inc., USAc6c22be1-659d-4e71-b292-701e27da201b2026-01-19Warnings, Adverse reactionsExact identifier
application number: ANDA091672
ndc (product): 68462-396
rxcui: 198051
rxcui: 200329
rxcui: 199119
spl id: 69b1e229-f845-4608-be48-f97e8d3e2273
spl set id: c6c22be1-659d-4e71-b292-701e27da201b
unii: KG60484QX9
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.fa0395a7-4353-4d64-9de8-d15857a7031c2026-01-13Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthwind Health Company, LLC10a3fbc9-00c6-ad83-e063-6294a90ae1ad2026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCf76c23d5-26b6-cfb2-e053-6294a90aea422026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCf3038133-8bb2-044e-e053-2995a90a6e7d2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthwind Health Company, LLC4720cc17-013e-074e-e063-6294a90ac1f42025-12-29Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCaae3bf9f-5d05-889f-e053-2995a90a5ff22025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9
OmeprazoleOMEPRAZOLERedpharm Drug2fd1acb8-12dc-70b7-e063-6394a90a03992025-12-25Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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