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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.631523e7-7d67-0cc3-e053-2a91aa0abb622024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINGland Pharma Limited95479f18-76dc-41cf-a359-922febeed0f22024-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINDr. Reddy's Laboratories Limited9b59428a-a23a-b2d9-982f-98f8a1ed381f2024-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINAurobindo Pharma Limited529ac72c-c4a0-4001-8cf9-b94f5bf7265c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACIN IN 5% DEXTROSEEugia US LLC7d3f83bf-2db7-4657-9538-406adf321ad52024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINANI Pharmaceuticals, Inc.a894e40b-77e4-439b-b0f8-9a5cc7a1dd902024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINEugia US LLC4d400bf9-988f-42ec-93f1-e71a93a324b22024-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.72cb9372-e9f8-3ca1-e053-2a91aa0ad8202024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLLEVOFLOXACINAdvanced Rx Pharmacy of Tennessee, LLC19afbe98-484c-c980-e063-6294a90acdc62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINFresenius Kabi USA, LLCeb30fafa-bbb9-458f-89df-ae610fa6aa962024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINAsclemed USA, Inc.2e32a8aa-047b-46c6-b67b-d88a9a0a810b2024-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINMacleods Pharmaceuticals Limitedfc165a6d-24b0-4753-a7ac-94a134dca0d32023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINProficient Rx LP95149cfb-1a71-42b7-b50d-9a2e943343392022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINProficient Rx LP30958610-3803-45e6-aa3c-d256decbe6e42019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINHikma Pharmaceuticals USA Inc.e680c759-16c5-4532-9c9c-f42c8c3df74a2019-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINHikma Pharmaceuticals USA Inc.f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba52019-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINBaxter Healthcare Corporation70c87464-1806-480a-8ebd-3f02987ff4362019-03-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF

Reported adverse events (FAERS/openFDA)#

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