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 76 of 128 · 2,546 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEAsclemed USA, Inc.9c41bcfa-b08b-3ac3-e053-2a95a90ae1c02025-02-13Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
unii: 15FIX9V2JP
OmeprazoleOMEPRAZOLEChartwell RX, LLC4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e2025-02-12Warnings, Adverse reactionsExact identifier
unii: KG60484QX9
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC2dcd48e4-9ffc-9cc2-e063-6294a90ae17e2025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 200329
unii: KG60484QX9
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp88021a24-d3b5-48f8-8d26-affbfcfd098f2025-02-10WarningsExact identifier
unii: 15FIX9V2JP
Swimmers FriendANTIMONIUM TART., ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, DIGITALIS PURPUREA, DROSERA, LACHESIS MUTUS, LACTICUM ACIDUM, LEDUM PALUSTRE, MAGNESIA CARBONICA, MANGANUM ACETICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHURICUM ACIDUM, VERBASCUM THAPSUS, VIPERA BERUSNewton Laboratories, Inc.9d260197-0c81-0df2-e053-2a95a90a44102025-02-10WarningsExact identifier
unii: 0E53J927NA
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b2e2194-fda3-6837-e053-2995a90ac61a2025-02-10WarningsExact identifier
unii: 0E53J927NA
Restless LegMYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORANewton Laboratories, Inc.9b3f076e-7edd-ea51-e053-2a95a90abd9b2025-02-10WarningsExact identifier
unii: 0E53J927NA
Gas-IndigestionCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUMNewton Laboratories, Inc.9a125a53-39c2-d849-e053-2a95a90a98452025-02-10WarningsExact identifier
unii: 0E53J927NA
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2dd20800-2cf9-02d4-e063-6294a90a0f002025-02-10WarningsExact identifier
unii: 15FIX9V2JP
Centella Calming SUNSCREENCENTELLA CALMING SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2dc0ee9b-d58b-fe40-e063-6394a90af4392025-02-09WarningsExact identifier
unii: 15FIX9V2JP
PROBIOTIC RICE SunscreenPROBIOTIC RICE SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2d9d6440-39b3-312a-e063-6394a90aa0722025-02-08WarningsExact identifier
unii: 15FIX9V2JP
Morning Sickness-NauseaCHAMOMILLA, HYDRASTIS CANADENSIS, IRIS VERSICOLOR, BISMUTHUM METALLICUM, BRYONIA, CIMICIFUGA RACEMOSA, GOSSYPIUM HERBACEUM, IPECACUANHA, KREOSOTUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PULSATILLA, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c4a6bf8-5f48-96a8-e053-2a95a90a97572025-02-07WarningsExact identifier
unii: 0E53J927NA
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENTZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cfe6a6-c2e4-8fb8-e063-6294a90adc782025-02-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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