NDC 0517-0761 - Ofloxacin

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
0517-0761
Package NDCs from labels
0517-0761-01
Manufacturer
American Regent, Inc. | PharmaForce, Inc.
Effective date
2010-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)American Regent, Inc. | PharmaForce, Inc.2010-07-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0517-0761-012019-10-21C16284748780-1956f9ecf-c04e-621f-e053-dbdaa90a74adOFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0761-01Ofloxacin10 mL in 1 BOTTLESOLUTION/ DROPS101
0517-0761-01Ofloxacin1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0761OFLOXACIN SOLUTION/ DROPS [AMERICAN REGENT, INC.]12 package rows20180616_227e11ab-4e07-4e34-b21d-ef965bae6272.zip

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 89 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
unii: F5UM2KM3W7
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.47a0313f-36df-4fa6-a828-c9e1946ba9b02024-05-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
unii: QTT17582CB
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCf0cc6713-4d47-49be-8116-901c99002b6b2024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.7f22c06b-6b4d-4b49-a4b2-d2169f2bd6532024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff2024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLC97001218-086c-430a-9e0d-6c7031c91d942024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCfe5b5182-c859-4c74-b2e0-467be5b2e3292024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.f2475fa3-ab1d-4b81-8127-b58cd0790a542024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Tork Hand Sanitizer Alcohol Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCd2e6d469-ddcc-4cad-829f-245dc1ec83682024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Tork Foam AntibacterialBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC45416b88-3703-4934-9439-9f23233427442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial Foam with Moisturizers Tranquil AloeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe0bded7-a268-db59-e053-6294a90aee442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
GP enMotion Antimicrobial FoamBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsc846eb52-3db4-1a74-e053-2a95a90aa84d2024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Pacific Blue ultra Antimicrobial Foam Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe165a79-6947-eb25-e053-6294a90a98f52024-05-02WarningsExact identifier
unii: F5UM2KM3W7
GP PBU Antimicrobial FoamBENZALKONIUM CHLORIDEGeorgia Pacific Consumer Productsc8d09207-d152-5abc-e053-2a95a90aaf922024-05-02WarningsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial Foam with Moisturizers Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfdb5776b-7d6c-84f9-e053-6394a90a0c392024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Pacific Blue ultra Antimicrobial Foam Pacific CitrusBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe1727b4-b016-74fc-e053-6394a90ad78a2024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Weed Grass AntigensALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,Energique, Inc.8a28f56a-6010-42e3-b360-e6e22b86222a2024-05-02WarningsExact identifier
unii: 451W47IQ8X
ofloxacinOFLOXACINProficient Rx LP0c4e0b81-a344-4678-97d2-b15dc28578822024-05-01Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H

Reported adverse events (FAERS/openFDA)#

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