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 12 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin/Clav Pot Oral SuspAMOXICILLIN/CLAV POT ORAL SUSPDirect_Rxe5bd9918-b073-c50b-e053-2a95a90aaeb72025-01-22Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxilAMOXICILLIN ORAL SUSPDirectRxec7dd735-dc92-3d29-e053-2a95a90af5492025-01-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINDirect_Rxf98c49a3-e6bb-7fc7-e053-6394a90a90622025-01-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
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
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.2bb03d3b-5d44-bc4a-e063-6394a90a656a2025-01-14Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
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
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
AmoxicillinAMOXICILLINAdvanced Rx Pharmacy of Tennessee, LLCf4c36acc-828d-323b-e053-2a95a90a4d1c2024-12-31Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf2024-12-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5c60cb1c-3baf-3af2-e053-2a91aa0ae2082024-12-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.59a546ed-84b7-a54a-e053-2991aa0a3a0d2024-12-26Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsaaf42367-153e-4525-af5f-f5f1c7d6c5592024-12-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackd7c0a364-d5d1-432d-823b-844a2d0b67802024-12-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackb9bcd4a4-d4ae-4460-9eff-e80439fafd6f2024-12-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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