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 8 of 12 · 232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVOFLOXACINLEVOFLOXACINGland Pharma Limitedba69722b-d7f2-4519-8a63-9ee91294c4992024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINBryant Ranch Prepack54a02488-586d-4c4e-8a35-68a067bdd6e32024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINBryant Ranch Prepackb7a614b0-f604-48e1-9919-21da8f939d932024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINBryant Ranch Prepack804ec547-5b89-4fd0-89b3-7445543e563e2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Exact identifier
unii: 6GNT3Y5LMF
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINCamber Pharmaceuticals, Inc.b43e9b51-568c-4d84-bbd1-d237120056c42024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals, Inc.4a405103-41e8-6a1f-e054-00144ff8d46c2024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINLupin Pharmaceuticals, Inc.4be13bd5-0c39-43c3-9232-b1226ccd4dbc2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.631523e7-7d67-0cc3-e053-2a91aa0abb622024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINGland Pharma Limited95479f18-76dc-41cf-a359-922febeed0f22024-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665497
rxcui: 1665515
rxcui: 1665507
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINDr. Reddy's Laboratories Limited9b59428a-a23a-b2d9-982f-98f8a1ed381f2024-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
LevofloxacinLEVOFLOXACINAurobindo Pharma Limited529ac72c-c4a0-4001-8cf9-b94f5bf7265c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACIN IN 5% DEXTROSEEugia US LLC7d3f83bf-2db7-4657-9538-406adf321ad52024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665497
rxcui: 1665515
rxcui: 1665507
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINANI Pharmaceuticals, Inc.a894e40b-77e4-439b-b0f8-9a5cc7a1dd902024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINEugia US LLC4d400bf9-988f-42ec-93f1-e71a93a324b22024-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.72cb9372-e9f8-3ca1-e053-2a91aa0ad8202024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6GNT3Y5LMF

Reported adverse events (FAERS/openFDA)#

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