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 18 of 19 · 375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINProficient Rx LP2c395111-c9c1-483e-a542-58b935ede6892023-08-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAsclemed USA, Inc.bfd67724-fb22-4eac-8ebd-555614c163292023-06-17Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINBryant Ranch Prepackc5d39ce2-8ae4-4bba-893f-a713afba18932023-04-17Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAsclemed USA, Inc.be1d1a44-7ef3-445d-9970-494921de4c9d2023-03-18Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions029a49f2-2132-4160-a0d6-2d108a456a222023-03-02Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LPd5eba477-e255-4d97-9e16-30543c2986802023-03-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions77265bcd-c05d-443a-84c4-6e5ac75ee42c2023-02-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions6c7bccff-00bf-46b0-a9ee-eb27d38d73772023-02-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.f05a27dd-5ced-4f62-8a0c-548c3a033f5e2022-12-13Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINAsclemed USA, Inc.fe9e12de-9be9-4211-9a58-c7ecd9e838d52022-11-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPa0d22635-0e11-448d-b151-6f6168c657232022-11-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP9cac2bf2-fb48-4e83-b953-61c4d55f7e192022-11-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP1e91c5ce-3482-47ca-92e7-e492196992d92022-10-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP7f75de78-2228-48e0-8405-bf631ca431ab2022-07-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LPde792ac6-4b3d-4d34-8e50-030b5bd830d72022-06-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP3a7248ca-2855-433e-aabc-42f0bb0db1182022-06-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP756545f1-77af-49a0-a697-4cced31711d42022-06-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPf17fddd3-aecc-456c-9b2b-f33b7fdb353e2022-05-02Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP5db8df09-4e06-4681-918d-29ca6b50b3ec2022-05-02Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP5b68b2bf-b581-4372-87be-a6394ee569612022-05-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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