FDA.reportPublic FDA data

NDC 0143-9720-01 - 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
0143-9720
Requested NDC
0143-9720-01
Package NDCs from labels
0143-9720-01, 0143-9720-24
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2019-03-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levofloxacin - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2019-03-28HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9720-01Levofloxacin150 mL in 1 BAGINJECTION, SOLUTION15012
0143-9720-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION2412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9720LEVOFLOXACIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20190329_e680c759-16c5-4532-9c9c-f42c8c3df74a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9720-01ML - Milliliter0143-97207145c2c4-c04c-4976-9710-f0a34cf662c812013-02-13
0143-9720-24ML - Milliliter0143-972089adbbf6-59a9-4b0e-8032-ec80c7dfec8a12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GLEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4

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 5 of 12 · 232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in DextroseDEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTIONICU Medical Inc.02d694b5-3600-4d55-bd5c-924abaec53152025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEICU Medical Inc.cdf35d11-fbc8-4f8e-85a8-33220312c0b42025-10-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.814450ae-439e-4a5d-8c60-9b21b6f14be52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b1a4aabb-42af-4133-8e82-0c7ec8fa79c32025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b8defac4-9deb-433b-928e-0ef4ee0123a22025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINBryant Ranch Prepackcbd5153f-fada-4682-b858-dc3b6e3173cc2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINA-S Medication Solutions1538ec66-f385-401e-8cfb-d794691e71762025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Companybfc4224a-2fc9-4137-b4c6-9d2d6d9484132025-07-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3842a9c0-8b15-1c94-e063-6394a90ae1202025-07-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: LX22YL083G
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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