FDA.reportPublic FDA data

NDC 68180-784-03 - 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
68180-784
Requested NDC
68180-784-03
Package NDCs from labels
68180-784-06, 68180-784-01, 68180-784-03
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2019-01-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OMEPRAZOLE - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2019-01-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-784-01OMEPRAZOLE100 in 1 BOTTLECAPSULE, DELAYED RELEASE1008
68180-784-03OMEPRAZOLE1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10008
68180-784-06OMEPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-784OMEPRAZOLE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]83 package rows20240101_be061124-0aa9-4bf5-ae58-adf8c3ed4204.zip

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 78 of 128 · 2,546 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLECoupler LLC2cdc6809-3b1b-046a-e063-6394a90ae02a2025-01-29Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Bowel-Digestive CareECHINACEA, JUGLANS REGIA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, IRIS VERSICOLOR, KALI BICHROMICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RAPHANUS SATIVUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM THAPSUS, ZINGIBER OFFICINALENewton Laboratories, Inc.9d60d399-6f63-5842-e053-2995a90a7cf72025-01-28WarningsExact identifier
unii: 0E53J927NA
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
unii: 15FIX9V2JP
DiarrheaAESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUSNewton Laboratories, Inc.9d7322da-c2fb-0fc3-e053-2a95a90ac70b2025-01-27WarningsExact identifier
unii: 0E53J927NA
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
unii: 15FIX9V2JP
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
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
unii: KG60484QX9
OmeprazoleOMEPRAZOLECVS Pharmacy64a62f09-19a9-4281-a55d-451fd33711c12025-01-17WarningsExact identifier
unii: KG60484QX9
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
unii: 15FIX9V2JP
dg health omeprazoleOMEPRAZOLEDolgencorp Inc6d19783d-2856-4a86-9f5c-6cc26b4ca33e2025-01-17WarningsExact identifier
unii: KG60484QX9

Reported adverse events (FAERS/openFDA)#

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