FDA.reportPublic FDA data

NDC 80425-0180-01 - 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
80425-0180
Requested NDC
80425-0180-01
Package NDCs from labels
80425-0180-1, 80425-0180-2, 80425-0180-3, 80425-0180-01
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
80425-0180-1Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED206
80425-0180-2Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED306
80425-0180-3Amoxicillin and Clavulanate Potassium14 in 1 BOTTLETABLET, FILM COATED146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0180AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 3 package rows20250204_d294e4a2-8ce7-418d-e053-2a95a90ab10b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0180-1EA - Each80425-0180444739e5-da19-41e1-8824-9f7dd13f80d412023-03-13
80425-0180-2EA - Each80425-0180d04fe114-f486-4525-b5ac-9899de674fcf12023-03-13
80425-0180-3EA - Each80425-0180bfa4e2cd-b009-4e92-9271-46e708d5316a12025-03-04

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 13 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 562508
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
rxcui: 617296
rxcui: 562508
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
rxcui: 617296
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals Inc.2177c68d-2884-ce70-e063-6294a90aa2672024-09-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPaad174d9-2c46-49aa-9a62-61063f405c532024-09-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.20eb4ade-f3b8-db66-e063-6294a90ae8462024-08-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions85721bc3-37eb-4db6-8a40-8a1412ac953a2024-08-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAsclemed USA, Inc.a18751fa-6202-4ae2-950a-a3f1dc9a8afd2024-08-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAsclemed USA, Inc.9cd42f6f-cc7a-43f5-98dd-a5d6210933ae2024-08-14Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5780c9e4-5e22-270c-e053-2a91aa0a36ba2024-08-14Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.554239db-69fe-405a-910a-d9f9e3f8b6ed2024-08-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP474c822b-dc3d-4a55-8159-2b4b799d535b2024-08-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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