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 16 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINBryant Ranch Prepackaee851cf-428e-4d29-a281-078fe00c56b02024-05-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINBryant Ranch Prepack9925773d-8ea1-4193-91e3-52cc1ce5ca672024-05-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack917a76e9-eb2b-4d49-9418-ff919a73cfad2024-05-29Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack71812ac4-9264-49f2-b9ab-ea1efd1af4522024-05-29Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINTeva Pharmaceuticals USA, Inc.4c0f348a-a65d-409c-8668-207c82a5e3cb2024-05-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsaaa35f65-cb9c-4b37-a126-c5ff2c2ef79d2024-05-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AugmentinAMOXICILLIN AND CLAVULANATE POTASSIUMAllegis Holdings, LLC04a31a42-d79e-bbb4-e063-6394a90a63ee2024-05-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions2718248d-d948-466e-959b-1a972519f1082024-05-14Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions14a5f8c2-fdaf-4ad4-982b-c5aa128e242d2024-05-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions7db086c6-a56b-4848-9eec-abaaff9f5b6f2024-05-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsd5ecb620-5267-4dcf-be81-64c7766516f52024-05-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsa2a5bb34-671b-499c-b8b4-c40fb51af09a2024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions3d8a700b-b23b-459a-a19a-213dd39b6a3a2024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsefc66d77-1733-41e1-9aed-7c10a4b4ba962024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions00cf4429-e37c-4490-b22d-3cd7961242962024-04-30Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions6a3d1af5-6e93-4f06-8d82-1c87290c46aa2024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions1dc5cc5a-59ba-4bc9-b581-cb7b70ce26522024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions322feb95-8bd4-440a-bda2-29ee19b112342024-04-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions4d0f063a-d896-4757-8f22-9614e2ad71d42024-04-11Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions73219f24-6eac-4472-b2a7-cad36936c1852024-04-11Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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