FDA.reportPublic FDA data

NDC 80425-0504-01 - Omeprazole

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
80425-0504
Requested NDC
80425-0504-01
Package NDCs from labels
80425-0504-1, 80425-0504-2, 80425-0504-3, 80425-0504-4, 80425-0504-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omeprazole - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-03-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0504-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
80425-0504-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
80425-0504-3Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901
80425-0504-4Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0504OMEPRAZOLE CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 4 package rows20250321_30955530-56d2-174d-e063-6294a90a413c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0504-1EA - Each80425-0504eadac093-b961-4f59-86df-6a0c5c7069a812025-05-14
80425-0504-2EA - Each80425-0504676f3a01-3925-44b6-a113-c81edc6e2a6a12025-05-14
80425-0504-3EA - Each80425-05041e7db351-dcd8-4bd4-8243-268c6791ffc112025-05-14
80425-0504-4EA - Each80425-050477ebe798-ffb7-4b8a-99ac-e491f4d6343512025-05-14

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 14 of 121 · 2,404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEA-S Medication Solutionsc1276463-7357-45b5-9f7e-8d3c4a550ff42026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OmeprazoleOMEPRAZOLEA-S Medication Solutionsdf1a4294-3893-4a11-b4d5-f3536678087e2026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
unii: 15FIX9V2JP
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
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
HYDRATING TINTED MOISTURIZER SPF50HYDRATING TINTED MOISTURIZER SPF50NING PTE. LTD.4cf8d3d3-eebf-2da0-e063-6294a90a70652026-03-14WarningsExact identifier
unii: 15FIX9V2JP
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Omeprazole DROMEPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCc8bf92c9-1bab-7985-e053-2995a90a02252026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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