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 3 of 12 · 232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.a5ae33ad-4703-4cb2-8618-6439c906be992026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Company8e7046f8-841e-465a-af69-af9fb3d6799d2026-03-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DEXTROSEDEXTROSEHF Acquisition Co. LLC. DBA HealthFirst4d2d3d3d-d96e-4005-e063-6394a90afd9a2026-03-16Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLC3b8f2692-4371-4f1a-95af-b41842131fdd2026-03-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEProPharma Distribution48c0ee87-f722-1a71-e063-6394a90a72d12026-01-19Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEB. Braun Medical Inc.7dff29d9-522d-40eb-a9d9-42377912d6402026-01-14Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.b8ac5047-5203-42c4-886b-dd0b08a1786f2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.16d51c1c-4144-4be7-9356-98fcee621ecd2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
DextroseDEXTROSE MONOHYDRATEBECTON DICKINSON AND COMPANY32132016-1870-481b-9816-e11beb03ca0b2026-01-08Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf2f090c2-3ee1-7689-e053-2995a90abe382026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf780bb91-483a-d1a6-e053-6294a90ab74b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNorthwind Health Company, LLCf33140d5-59ad-3379-e053-2995a90ae2862026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINBPI LABS LLCb6d9740b-2f9d-4f1c-bc9b-4c2150b22f102025-12-26Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF

Reported adverse events (FAERS/openFDA)#

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