FDA.reportPublic FDA data

NDC 80425-0279-01 - 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
80425-0279
Requested NDC
80425-0279-01
Package NDCs from labels
80425-0279-1, 80425-0279-2, 80425-0279-3, 80425-0279-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2025-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin and Clavulanate Potassium - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2025-02-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0279-1Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED203
80425-0279-2Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED303
80425-0279-3Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0279AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 3 package rows20250204_f601c634-2271-2fcd-e053-2995a90aaaba.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0279-1EA - Each80425-0279deca8df9-5797-4f1c-b6e7-df35b467be0d12023-04-07
80425-0279-2EA - Each80425-0279f9079f26-45d5-453d-848e-27c87efc1afb12023-04-07
80425-0279-3EA - Each80425-02790832f42e-e1b2-4437-b7f9-e67bdd962b6d12025-03-04

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 1 of 20 · 381 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOXICILLINAMOXICILLINREMEDYREPACK INC.4adc198e-39d8-4b3e-bfa4-278aaf4064ae2026-09-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLINAMOXICILLINChartwell RX, LLCb07b5ac4-253e-4c83-91c3-3fdc46e91a0f2026-09-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.b6ea2f81-aee6-4c88-b681-50eb28e80a862026-09-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINRedpharm Drug5a79669f-52f7-e8ea-e063-6394a90a93b82026-09-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.f37eb415-77b2-41b0-8d20-64e821e4b05d2026-09-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLINAMOXICILLINRedpharm Drug5a660370-9a81-33f9-e063-6394a90a6c622026-09-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.a26f2ceb-bb9b-4813-9691-6343381868602026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLC69e45bc0-de57-4603-a9eb-335988dfe0bf2026-08-29Warnings, Adverse reactionsExact identifier
application number: ANDA091568
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINSportpharm LLCc4d4aeca-f63c-4548-a9b7-7f627e8fd45c2026-08-29Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.e5b0770d-1301-498e-a4ed-41874d7bf2252026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.7526a33a-18d6-36ca-e053-2a91aa0ab9f92026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions4937611d-bd61-4538-ad1e-bd67e95279552026-08-25Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.1bda03a2-6c7d-4c9e-b98a-e5e01bebb3b12026-08-24Warnings, Adverse reactionsExact identifier
application number: ANDA091568
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.82c0c5d1-df2d-4352-bd12-99f955af569e2026-08-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.3a4afd36-dffa-44a1-9d09-e93cf66053bf2026-08-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.c88b2b50-c664-43b3-9c37-f134a329dc212026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.80bef3fd-4f6f-4190-8865-9ac46c8947a32026-08-14Warnings, Adverse reactionsExact identifier
application number: ANDA091568
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.a1d6bf78-4bb7-469e-ba39-318e14aaee292026-08-13Warnings, Adverse reactionsExact identifier
application number: ANDA091568
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAurobindo Pharma Limited3ae0c95f-7ffa-4317-9fea-4d07b86bee722026-08-13Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.fbd40fcd-bf5b-e91e-e053-6394a90a609c2026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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