FDA.reportPublic FDA data

NDC 59115-024-01 - Amoxicillin and Clavulanate Potassium

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
59115-024
Requested NDC
59115-024-01
Package NDCs from labels
59115-024-01, 59115-024-50, 59115-024-75
Manufacturer
Hikma Pharmaceutical
Effective date
2015-03-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin and Clavulanate Potassium - Hikma PharmaceuticalHikma Pharmaceutical2015-03-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICAL]5

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 29 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINDirect_Rxf98c49a3-e6bb-7fc7-e053-6394a90a90622025-01-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Bestmade Natural Products BM5APIS MELD3, BAPTISIAD4, CONIUM MACD8, ECHINACEAD2, EUPATORIUMD4, SILICEAD6, THUJA OCCD8Bestmade Natural Productsebdcb53e-1767-cd08-e053-2995a90aedeb2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio18CALC FLUOR, SILICEA, CALC SULPHBestmade Natural Productseac337aa-11a1-5b17-e053-2a95a90ad19d2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxcdc6d30a-754e-6672-e053-2a95a90afa7f2025-01-20Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AMOXICILLINAMOXICILLINDirectRxcedde8f5-aadd-53de-e053-2995a90aab162025-01-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.2bb03d3b-5d44-bc4a-e063-6394a90a656a2025-01-14Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
D-34OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLADNA Labs, Inc.607e21a3-2229-48fa-b12c-ebd3130b99962025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-33ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINCDNA Labs, Inc.26f9bf6d-6038-42e8-b8c1-6c94ac4929af2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-57ARSENIC TRIIODIDE, PHOSPHORUS, TEUCRIUM SCORODONIA FLOWERING TOP, SILICON DIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND LYCOPODIUM CLAVATUM SPOREDNA Labs, Inc.81cc16e7-921b-4b57-abeb-c44b9d72e4f32025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-48PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATEDNA Labs, Inc.1d55827f-0ea2-4eda-ae43-7c0723e5708e2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-132SILICON DIOXIDEDNA Labs, Inc.3d8e499d-ebe2-45b9-b078-256268c42d4b2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-117ATROPA BELLADONNA AND SILICON DIOXIDEDNA Labs, Inc.8bcce284-f8f3-4d62-a13e-b93c2c655a702025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-109ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLEDNA Labs, Inc.7758341d-e0be-487a-ba47-8847551231e12025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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