FDA.reportPublic FDA data

NDC 80425-0077-01 - Levofloxacin

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
80425-0077
Requested NDC
80425-0077-01
Package NDCs from labels
80425-0077-1, 80425-0077-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0077-1Levofloxacin14 in 1 BOTTLETABLET, FILM COATED146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0077LEVOFLOXACIN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 1 package rows20250101_b001d60e-b8fb-54ff-e053-2a95a90a2970.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0077-1EA - Each80425-0077158c2c5f-2e17-4f7e-8612-036b1ce2260e12023-06-06

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 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINRedpharm Drug5a65b2bc-9edc-f193-e063-6394a90a01042026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199884
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINCoupler LLC59f387a4-4dfa-ba71-e063-6294a90a340c2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINMajor Pharmaceuticalsac4001ca-882f-4d9b-a570-c1b9d7fd68302026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINBryant Ranch Prepackb9dc8bf3-97d9-4d1c-9a68-3ae553acdada2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINSagent Pharmaceuticals699fbdb8-a6fd-476a-9b80-08197d8695342026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINHAWAII REPACK, INC.857f256c-88ac-4f73-9815-c2724edf2f1e2026-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.2a4e97e0-0709-411b-92e8-6f7d669412e42026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.710c0c10-89a5-4954-8f74-acc187c5cf0f2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINChartwell RX, LLC5c6c117c-9d91-48f4-9aaa-ee70b99218c22026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.f14cf651-a213-4a4f-adb9-f628562af27c2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINCardinal Health 107, LLC070375be-3b67-4299-ae8f-4a7b157ac16f2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.bcad1dad-53aa-43dd-90f3-cc17cc9598d52026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.2a8676a9-247f-4fdb-b644-e9785d98771f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 311296
unii: 6GNT3Y5LMF
LEVOFLOXACINLEVOFLOXACINDIRECT RX4f40d5fa-ebcc-516c-e054-00144ff8d46c2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.a5ae33ad-4703-4cb2-8618-6439c906be992026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF

Reported adverse events (FAERS/openFDA)#

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