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 4 of 12 · 232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINST. MARY'S MEDICAL PARK PHARMACY46a3c619-b2a3-3f28-e063-6394a90a23092025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.c6027cde-b9fe-e593-e053-2995a90ac2c12025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: LX22YL083G
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: LX22YL083G
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: LX22YL083G
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: LX22YL083G
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINHospira, Inc5a1534af-aa1c-4f1d-ba9f-9415b14e1af22025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665497
rxcui: 1665515
rxcui: 1665507
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSEICU Medical Inc.b5cb7a5a-bbe8-4217-a82e-da818f7771c92025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.cb578dba-094c-4787-951d-763d12fd06e12025-11-01Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINVERITYRX, LLC427a2077-5dbb-3c5e-e063-6294a90a08392025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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