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 6 of 12 · 232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINProficient Rx LP64141d0d-0347-470f-a427-9925a2eb357e2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation36e9478c-5df0-4b47-b97d-de3626d7cb292025-06-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC67bee807-7ba8-4e92-81f2-c888118d277e2025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0fb30b7e-8e1b-49c7-afac-2d5c01b9ff452025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb0f2c9a2-d9d4-4907-a324-e7a26d489f442025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCa829d4eb-3ec5-453c-b270-793969af15b32025-05-09Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC50fc30a0-0eca-452e-825e-08c2647ccfc12025-05-08Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb2b780d3-26ac-4e7c-a0f2-78991bee32a82025-05-07Exact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINRedpharm Drug0a0fd993-7bea-42d8-e063-6394a90a4e0e2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: LX22YL083G
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
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.80501b71-2f08-2ef5-e053-2991aa0a6e862025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
levofloxacinLEVOFLOXACINCoupler LLC2cee61b7-be51-0fe5-e063-6294a90af9e32025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Glucose and Sodium ChlorideDEXTROSE ANHYDROUS AND SODIUM CHLORIDEBaxter Healthcare Corporation1ba918d0-13d0-48bc-8742-658fc0eb47b62025-01-24Exact identifier
unii: LX22YL083G
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: LX22YL083G
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc067e260c-dc47-4957-a9ff-5a79f17b4ca02025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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