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 11 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.f229e8b4-7045-4c0d-9214-890c0bda3c2a2026-02-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a42026-02-13Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions483f6fca-e04e-4086-aa44-a361322b811d2026-02-13Warnings, Adverse reactionsExact identifier
application number: ANDA065191
unii: 804826J2HU
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINA-S Medication Solutions8bce45db-dea7-4090-9d64-8b11b08d963e2026-02-12Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.800f5fac-f2af-358f-e053-2a91aa0ad6a62026-02-10Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions2a376d67-0bf2-43a1-8ca3-73f90689c3392026-02-06Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLC94b7c1bb-c024-4dc6-86d4-18a17a3eafcb2026-02-04Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINSportpharm LLCd55dd9d9-e901-47b6-b496-5f2749726a2e2026-02-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
Mold, Yeast and DustACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEANaturalCaree0f53f47-acd9-43e2-a7a2-2a500bc9dc1b2026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINREMEDYREPACK INC.bb95fd06-f200-4de3-bfae-84d642d8e0f32026-02-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.776da91b-0626-1090-e053-2a91aa0a40f02026-01-28Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.6a3f7e6c-fec2-41da-a070-00a02e64c9202026-01-28Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPreferred Pharmaceuticals, Inc.88e76bdd-39f2-48c4-91ca-609511afd3822026-01-26Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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