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 16 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 562508
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
AmoxicillinAMOXICILLINA-S Medication Solutions26202694-cf20-4b08-90cc-70a3d30cbb0f2024-04-11Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthStar Rx LLC843f6053-63d9-47d2-81f1-b6aa78a7c20c2024-03-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMMedsource Pharmaceuticals12a00e7e-80f5-7c5e-e063-6394a90a68d22024-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA204755
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP6a9cfa97-3715-4b75-a1e3-932a34a942d42024-03-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMMedsource Pharmaceuticals1275ad58-c53f-20d0-e063-6394a90a4a432024-02-28Warnings, Adverse reactionsExact identifier
rxcui: 617296
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.c8591c2a-92ef-4432-b19a-bb46063047ee2024-02-28Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.bbe590a0-4196-4885-b679-cc1833af567f2024-02-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINSandoz Inc13bd4214-9b7f-425b-af5f-fc1ddc6782302024-02-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.116f655e-e32f-5030-e063-6394a90a64e52024-02-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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