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 30 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
AM-9SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLEDNA Labs, Inc.d7a00f0b-de4c-4bff-b8e0-86a82bed8bb92025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-8SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARYDNA Labs, Inc.c25cdcb5-9469-48bb-b216-0a9d8d644e122025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-23ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.b6365b49-06fb-4692-96f7-a5097b70bc912025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-18OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLANDDNA Labs, Inc.3565c5d5-dc68-4f3f-99ec-30f8952393e02025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
NO-WEAK-NAILSGRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, AND SILICON DIOXIDEMiers Laboratories9158cd3f-4c27-40e9-bc07-fd560375c3a12025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.6d7143e3-6a82-3613-e053-2a91aa0a8f652025-01-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions5b2a2e62-6fd2-4ab1-b936-8702e68233fa2025-01-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Inc99b7f40a-06f9-4b97-8eee-8e61e5106aad2025-01-08Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.c84082fc-ea07-4e73-99c5-8356b957a1c52025-01-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthwind Pharmaceuticals, LLC26114563-c719-46da-b976-3e4271533f282025-01-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd2025-01-02Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.abbebdc1-4410-76af-e053-2a95a90acb9c2025-01-02Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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