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 15 of 122 · 2,433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
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
application number: ANDA078490
rxcui: 200329
unii: KG60484QX9
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
omeprazoleOMEPRAZOLEMeijer, Inc.47c41c68-cb20-40f0-9d85-ea8db33284782026-03-06WarningsExact identifier
rxcui: 198051
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited603d2d06-c5e8-4378-a422-8dca1a410af72026-03-02Warnings, Adverse reactionsExact identifier
application number: ANDA078490
ndc (product): 55111-644
rxcui: 198051
rxcui: 200329
rxcui: 199119
spl id: 8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
spl set id: 603d2d06-c5e8-4378-a422-8dca1a410af7
unii: KG60484QX9
OmeprazoleOMEPRAZOLENorthStar Rx LLC40a75dc7-49b7-5c9d-6c5f-d4682ec6922e2026-03-02Warnings, Adverse reactionsExact identifier
application number: ANDA078490
rxcui: 198051
rxcui: 200329
rxcui: 199119
unii: KG60484QX9
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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