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 13 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack9bd9e662-0b80-45a8-906b-3dc04ee6b3ba2024-12-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMTeva Pharmaceuticals USA, Inc.e83f43dd-f79e-4166-9bee-9427e235c8762024-12-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINBryant Ranch Prepackbef50f2a-78c6-4d0c-8ad9-cfa3c801629d2024-11-25Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.26469497-14c2-adb2-e063-6394a90af30a2024-11-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAsclemed USA, Inc.a56d7a5e-2b2c-4121-9d9c-a3283b3cebf92024-11-05Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionse13cafe2-f226-4021-81d8-7bd1f98b55822024-11-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions05e88717-2ce3-4b1a-88af-c3f61a2d8cd52024-11-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions0b5acc3f-c474-4b16-9d66-8048abb3b22d2024-11-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions5edc5d32-43d5-4418-9832-40363a919edc2024-11-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c62024-11-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions67b8567a-bab7-4859-88d6-c2ea695b9f0a2024-10-30Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMCipla USA Inc.db25500a-90ee-429f-991f-da511cec78822024-10-28Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.fc5dc69a-3c23-49fc-b80f-1412aebc9b762024-10-24Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.963986fc-0e59-21b0-e053-2a95a90a95312024-10-10Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsc3d3f94f-e976-4625-9667-3d716932f2fa2024-10-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLINAMOXICILLINMicro Labs Limited42f935ca-45ba-4b3e-8b40-9b2d4eb562812024-10-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP482511ed-4531-45ec-a4eb-c600aeb033252024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP52e676e4-b70e-4e73-bbe7-f54d91ca7e0a2024-10-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMDevatis, Inc.d25c8190-3690-4ce6-a525-21850754224d2024-09-30Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals Inc.2177c68d-2884-ce70-e063-6294a90aa2672024-09-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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