FDA.reportPublic FDA data

NDC 85534-0064-01 - 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
85534-0064
Requested NDC
85534-0064-01
Package NDCs from labels
85534-0064-0, 85534-0064-1, 85534-0064-2, 85534-0064-3, 85534-0064-01
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-07-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omeprazole - HAWAII REPACK, INC.HAWAII REPACK, INC.2026-07-13HUMAN PRESCRIPTION DRUG LABEL

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 64 of 117 · 2,327 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC003123d2-9675-fdd2-e063-6294a90a01302025-07-28WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20e0badf-fe25-1d27-e063-6294a90a7cfe2025-07-28WarningsExact identifier
unii: 15FIX9V2JP
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMGericare Pharmaceuticals0e1f5d7c-5956-3be7-e054-00144ff8d46c2025-07-28WarningsExact identifier
rxcui: 198051
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
unii: 15FIX9V2JP
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
unii: 15FIX9V2JP
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMHEB5d8b3f5f-f680-64ae-b360-c0bd06b2ac922025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMCVS Health Corp.3bbfa87d-f8b7-19bd-9f12-39cba31ae0b32025-07-23WarningsExact identifier
rxcui: 198051
OmeprazoleOMEPRAZOLEPHOENIX RX LLC3a9baece-03be-6c77-e063-6394a90a70322025-07-23Warnings, Adverse reactionsExact identifier
application number: ANDA091672
rxcui: 198051
unii: KG60484QX9
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationab5d339b-2c02-611d-d5db-8e1891684fe02025-07-23WarningsExact identifier
rxcui: 198051
Acid ReducerOMEPRAZOLE MAGNESIUMLEADER/ Cardinal Health 110, Inc.1dc00f13-d1f5-15a0-32cc-4fc041865e722025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMAlbertsons Companies302b1332-181b-834b-4154-d849cb3a1ef02025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Incdaeeba93-29d5-efb4-a591-3e72c4e503412025-07-23WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESThe Kroger Co.8a6bbc31-7c50-a730-4233-e346fd7eb5ba2025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.fe0eb905-2042-aed1-a67d-a219e76f679b2025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMWalgreens Companyee8b1740-9bcf-5b70-bd8d-97f98303dc722025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESWal-Mart Stores Inc3160e212-9ee9-8316-f51e-4628862f654c2025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Consortium, LLC39ac65c0-d957-125f-f00b-e3846a4374892025-07-22WarningsExact identifier
rxcui: 198051
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationfdf1259b-e9d3-70a9-c209-e2eb6b1528412025-07-22WarningsExact identifier
rxcui: 198051
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.f873dc20-c817-5e4f-e053-6394a90a04f22025-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198051
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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