FDA.reportPublic FDA data

NDC 80425-0198-01 - Cefadroxil

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
80425-0198
Requested NDC
80425-0198-01
Package NDCs from labels
80425-0198-2, 80425-0198-1, 80425-0198-3, 80425-0198-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefadroxil - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-02-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0198-1Cefadroxil10 in 1 BOTTLECAPSULE106
80425-0198-2Cefadroxil30 in 1 BOTTLECAPSULE306
80425-0198-3Cefadroxil20 in 1 BOTTLECAPSULE206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0198CEFADROXIL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 3 package rows20240210_ec836a53-7ed1-79b9-e053-2a95a90a9c36.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0198-1EA - Each80425-0198fa6bd022-72c2-49de-bfe1-dfbaf2458edb12023-06-06
80425-0198-2EA - Each80425-019860265ca7-1c82-4fa4-9812-67a2a18e68ac12023-06-06
80425-0198-3EA - Each80425-019888c9d8eb-6a94-4384-b6a3-712df226078912024-03-12

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.a218d8d3-af90-4599-e053-2995a90a0ede2024-06-20Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.8bdd68a4-4e2e-0170-e053-2a95a90adb782024-06-18Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.7278a39f-9de1-c9e2-e053-2a91aa0aea342024-06-10Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILAdvanced Rx Pharmacy of Tennessee, LLC1a50b564-b00f-58e4-e063-6294a90af2c62024-06-07Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.16f3dd01-650a-2426-e063-6394a90a1b4b2024-04-25Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILBryant Ranch Prepack672519a7-11a1-4d8e-b2ca-dc9598c2f1792024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILBryant Ranch Prepack9c3bed82-6df0-4643-944a-a826f7dc018f2024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILBryant Ranch Prepack8cdaac56-b84a-4b6b-b94d-cab15d5961c52024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILA-S Medication Solutions41ab333a-fafb-4647-844e-f3b2a76723cb2024-02-15Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILAdvanced Rx Pharmacy of Tennessee, LLCec836a53-7ed1-79b9-e053-2a95a90a9c362024-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA065352
ndc (package): 80425-0198-2
ndc (package): 80425-0198-3
ndc (package): 80425-0198-1
ndc (product): 80425-0198
ndc11 (package): 80425019801
rxcui: 309049
spl id: 10f671c2-e1e0-da2f-e063-6394a90a8724
spl set id: ec836a53-7ed1-79b9-e053-2a95a90a9c36
unii: 280111G160
CefadroxilCEFADROXILNorthStar Rx LLC30bb3686-87b4-4676-9ff5-e20deb8bff9d2024-02-09Warnings, Adverse reactionsExact identifier
unii: 280111G160
CefadroxilCEFADROXILRising Pharma Holdings, Inc.6e4111d3-f11b-403c-b340-b216022709df2024-02-09Warnings, Adverse reactionsExact identifier
unii: 280111G160
CefadroxilCEFADROXILAurobindo Pharma Limited776a8dbc-e68e-4732-acf4-0133dca0f54c2024-02-09Warnings, Adverse reactionsExact identifier
unii: 280111G160
CefadroxilCEFADROXILRising Pharma Holdings, Inc.74c99fd8-16d1-4d2c-9158-42ff5eed2b7c2024-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA065352
ndc (product): 57237-096
rxcui: 309049
spl id: 15dc4c1d-6a9a-4c87-a037-e6fc34d84ad9
spl set id: 74c99fd8-16d1-4d2c-9158-42ff5eed2b7c
unii: 280111G160
CefadroxilCEFADROXILAurobindo Pharma Limited7bb90096-14d3-400e-94d3-048bff6b12922024-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160
CefadroxilCEFADROXILNorthStar Rx LLC17123057-58c7-401a-b87d-8c4c0764bbf62024-01-30Warnings, Adverse reactionsExact identifier
application number: ANDA065352
rxcui: 309049
unii: 280111G160

Reported adverse events (FAERS/openFDA)#

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