FDA.reportPublic FDA data

NDC 0143-9316-01 - 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
0143-9316
Requested NDC
0143-9316-01
Package NDCs from labels
0143-9316-01, 0143-9316-24
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A.
Effective date
2019-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LevofloxacinHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A.2019-03-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9316-01Levofloxacin100 mL in 1 BAGINJECTION, SOLUTION1005
0143-9316-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9316LEVOFLOXACIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20190329_f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9316-01ML - Milliliter0143-93164d4431eb-01b7-482c-9e37-ec9e02b0a9d612018-12-13
0143-9316-24ML - Milliliter0143-9316615dd082-9432-4c12-86c0-84dbdbab735712018-12-13

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 12 · 232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: LX22YL083G
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: LX22YL083G
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.672264e3-9709-4bba-2a9d-12bf70c7396a2026-06-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.10e98cb0-31a5-4ad1-3eaa-aa4af387a42d2026-06-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINCardinal Health 107, LLC070375be-3b67-4299-ae8f-4a7b157ac16f2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.bcad1dad-53aa-43dd-90f3-cc17cc9598d52026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.2a8676a9-247f-4fdb-b644-e9785d98771f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSEB. Braun Medical Inc.60b6d7c3-0164-46c9-aa38-b5aa1c31a5d52026-05-12Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LEVOFLOXACINLEVOFLOXACINDIRECT RX4f40d5fa-ebcc-516c-e054-00144ff8d46c2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.40fd1ac4-39bb-45fb-ba99-4fb65481f2312026-04-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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