FDA.reportPublic FDA data

NDC 69043-021 - 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
69043-021
Package NDCs from labels
69043-021-21
Manufacturer
Cronus Pharma LLC
Effective date
2025-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin and Clavulanate Potassium - Cronus Pharma LLCCronus Pharma LLC2025-05-30PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69043-021-21Amoxicillin and Clavulanate Potassium14 in 1 BLISTER PACKTABLET, COATED143
69043-021-21Amoxicillin and Clavulanate Potassium15 in 1 CARTONTABLET, COATED153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69043-021AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED [CRONUS PHARMA LLC]22 package rows20210812_fff5e249-2f28-482f-b6ac-e13b5bad3c79.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 17 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINA-S Medication Solutions26202694-cf20-4b08-90cc-70a3d30cbb0f2024-04-11Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthStar Rx LLC843f6053-63d9-47d2-81f1-b6aa78a7c20c2024-03-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMMedsource Pharmaceuticals12a00e7e-80f5-7c5e-e063-6394a90a68d22024-03-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP6a9cfa97-3715-4b75-a1e3-932a34a942d42024-03-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMMedsource Pharmaceuticals1275ad58-c53f-20d0-e063-6394a90a4a432024-02-28Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.c8591c2a-92ef-4432-b19a-bb46063047ee2024-02-28Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.bbe590a0-4196-4885-b679-cc1833af567f2024-02-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINSandoz Inc13bd4214-9b7f-425b-af5f-fc1ddc6782302024-02-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.116f655e-e32f-5030-e063-6394a90a64e52024-02-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP0d40bc70-8f47-48c2-a7c6-ba7db9cace742024-02-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.d46f1091-33dc-4f8f-9c34-75dcfedb4b4c2024-02-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.077f4a65-3cfb-4cb1-99f2-e27ffc5939c02024-02-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAurobindo Pharma Limited7e3a4517-1934-4e03-b96b-4ad65ab076c52024-01-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLINAMOXICILLINDIRECT RX0173e9de-a995-4386-bb65-8fc2bbf347f92024-01-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP66404ced-5ef4-4a31-9276-8c6f86add61c2024-01-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LPfcdaba34-373f-4d4e-8203-76f02e3bb00a2024-01-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions00fbd46e-05fd-4f8a-9f59-a7a4d01c8e542023-12-18Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionscef5b1ae-8454-4e7a-8830-dd5d601c1d212023-12-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsca2886d0-7be7-4d41-bad5-df3ad44e0e7e2023-12-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions4eee2b38-ca84-421d-87e1-031bc5a3f3a72023-11-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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