FDA.reportPublic FDA data

NDC 0409-4444-01 - 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
0409-4444
Requested NDC
0409-4444-01
Package NDCs from labels
0409-4444-01, 0409-4444-24
Manufacturer
Hospira, Inc | InfoRLife SA | Infomed Fluids Srl
Effective date
2025-11-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - Hospira, Inc | InfoRLife SA | Infomed Fluids SrlHospira, Inc | InfoRLife SA | Infomed Fluids Srl2025-11-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4444-01Levofloxacin150 mL in 1 BAGINJECTION, SOLUTION1502
0409-4444-01Levofloxacin1 in 1 POUCHINJECTION, SOLUTION12
0409-4444-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4444LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC]1Current NDC, 3 package rows20240520_5a1534af-aa1c-4f1d-ba9f-9415b14e1af2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4444-01ML - Milliliter0409-4444c6cf94c2-814d-4cd1-9c50-019bbab776f512024-07-12
0409-4444-24ML - Milliliter0409-4444cf67e215-03e0-4924-9baa-c8ba2a3e27ed12024-07-12

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 13 of 20 · 393 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINBryant Ranch Prepack804ec547-5b89-4fd0-89b3-7445543e563e2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Exact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINCamber Pharmaceuticals, Inc.b43e9b51-568c-4d84-bbd1-d237120056c42024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals, Inc.4a405103-41e8-6a1f-e054-00144ff8d46c2024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
LevofloxacinLEVOFLOXACINLupin Pharmaceuticals, Inc.4be13bd5-0c39-43c3-9232-b1226ccd4dbc2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.631523e7-7d67-0cc3-e053-2a91aa0abb622024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINGland Pharma Limited95479f18-76dc-41cf-a359-922febeed0f22024-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665497
rxcui: 1665515
rxcui: 1665507
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINDr. Reddy's Laboratories Limited9b59428a-a23a-b2d9-982f-98f8a1ed381f2024-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINAurobindo Pharma Limited529ac72c-c4a0-4001-8cf9-b94f5bf7265c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACIN IN 5% DEXTROSEEugia US LLC7d3f83bf-2db7-4657-9538-406adf321ad52024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665497
rxcui: 1665515
rxcui: 1665507
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
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.72cb9372-e9f8-3ca1-e053-2a91aa0ad8202024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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