FDA.reportPublic FDA data

NDC 0409-3330-01 - 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
0409-3330
Requested NDC
0409-3330-01
Package NDCs from labels
0409-3330-01, 0409-3330-24
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
0409-3330-01Levofloxacin100 mL in 1 BAGINJECTION, SOLUTION1002
0409-3330-01Levofloxacin1 in 1 POUCHINJECTION, SOLUTION12
0409-3330-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3330LEVOFLOXACIN 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
0409-3330-01ML - Milliliter0409-3330c9783ebb-a246-42ab-a375-e34bbce14fe512024-07-12
0409-3330-24ML - Milliliter0409-333022048d6e-ee4e-4225-a2f1-1050a8c3f31a12024-07-12

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 1 of 20 · 395 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINRedpharm Drug5a65b2bc-9edc-f193-e063-6394a90a01042026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
levofloxacinLEVOFLOXACINCoupler LLC59f387a4-4dfa-ba71-e063-6294a90a340c2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LevofloxacinLEVOFLOXACINMajor Pharmaceuticalsac4001ca-882f-4d9b-a570-c1b9d7fd68302026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
levofloxacinLEVOFLOXACINBryant Ranch Prepackb9dc8bf3-97d9-4d1c-9a68-3ae553acdada2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LevofloxacinLEVOFLOXACINSagent Pharmaceuticals699fbdb8-a6fd-476a-9b80-08197d8695342026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090343
rxcui: 1665497
rxcui: 1665515
rxcui: 1665507
unii: 6GNT3Y5LMF

Reported adverse events (FAERS/openFDA)#

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