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 2 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.b8ac5047-5203-42c4-886b-dd0b08a1786f2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.16d51c1c-4144-4be7-9356-98fcee621ecd2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf2f090c2-3ee1-7689-e053-2995a90abe382026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf780bb91-483a-d1a6-e053-6294a90ab74b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf33140d5-59ad-3379-e053-2995a90ae2862026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINBPI LABS LLCb6d9740b-2f9d-4f1c-bc9b-4c2150b22f102025-12-26Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINST. MARY'S MEDICAL PARK PHARMACY46a3c619-b2a3-3f28-e063-6394a90a23092025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.c6027cde-b9fe-e593-e053-2995a90ac2c12025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINHospira, Inc5a1534af-aa1c-4f1d-ba9f-9415b14e1af22025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINVERITYRX, LLC427a2077-5dbb-3c5e-e063-6294a90a08392025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.814450ae-439e-4a5d-8c60-9b21b6f14be52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b1a4aabb-42af-4133-8e82-0c7ec8fa79c32025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b8defac4-9deb-433b-928e-0ef4ee0123a22025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINBryant Ranch Prepackcbd5153f-fada-4682-b858-dc3b6e3173cc2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311296
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINA-S Medication Solutions1538ec66-f385-401e-8cfb-d794691e71762025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
rxcui: 311296
rxcui: 199884
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINProficient Rx LP64141d0d-0347-470f-a427-9925a2eb357e2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINRedpharm Drug0a0fd993-7bea-42d8-e063-6394a90a4e0e2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199885
unii: 6GNT3Y5LMF
LEVOFLOXACINLEVOFLOXACINAdvagen Pharma Limitedf2eb9444-333d-4b05-8cf3-2e6690a2bf992025-03-10Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.05d179f5-b200-8597-e063-6394a90a10cc2025-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202801
rxcui: 199885
unii: 6GNT3Y5LMF

Reported adverse events (FAERS/openFDA)#

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