FDA.reportPublic FDA data

NDC 0517-0761-01 - 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
Requested NDC
0517-0761-01
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 84 of 111 · 2,209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ofloxacin OticOFLOXACINA-S Medication Solutions9d4b1225-e20d-4ace-850a-506fd031cac72024-07-18Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
OfloxacinOFLOXACIN OTICAmneal Pharmaceuticals NY LLCba37e2a0-1bf7-41ca-bddd-35fcb77f87de2024-07-18Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
OfloxacinOFLOXACINNuCare Pharmaceuticals,Inc.af861f20-5ec8-2883-e053-2a95a90a23122024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
OfloxacinOFLOXACINNuCare Pharmaceuticals,Inc.ae6b5cb0-aa18-a6d2-e053-2995a90a525d2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
Ofloxacin OticOFLOXACINNuCare Pharmaceuticals,Inc.79ef87c3-1f09-1625-e053-2991aa0a84ae2024-07-17Warnings, Adverse reactionsExact identifier
unii: A4P49JAZ9H
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.de3b8c33-0d6c-49a9-8243-0d52284770f42024-07-12WarningsExact identifier
unii: F5UM2KM3W7
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.7345c155-b5f2-4d29-b469-1153e103cc892024-07-12WarningsExact identifier
unii: F5UM2KM3W7
Novex Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.7832a0be-a8ce-4b56-a9bb-a375b97df2872024-07-10WarningsExact identifier
unii: F5UM2KM3W7
Callington Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.00ca48ca-893d-4a3f-ad90-119522664e082024-07-10WarningsExact identifier
unii: F5UM2KM3W7
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.388ca447-2267-419f-acec-17b808b27a5a2024-07-10WarningsExact identifier
unii: F5UM2KM3W7
Pure ForceBENZALKONIUM CHLORIDEEcolab Inc.66fd73be-05c8-4905-96f5-f73fa1447b3f2024-07-09WarningsExact identifier
unii: F5UM2KM3W7
Sani Luxe Foaming Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDECeleste Industries Corporation7549428e-b10f-45b9-b414-0c6e8b41c3982024-07-08WarningsExact identifier
unii: F5UM2KM3W7
OFLOXACINOFLOXACINLeading Pharma, LLC7552729e-a41e-4eb1-8b37-b48a861127902024-07-01Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.dfff78d2-e23c-40b2-8a49-8f4140bb0df62024-06-25WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial FoamSoapBENZALKONIUM CHLORIDEFerguson Enterprises18f9c948-74aa-ae19-e063-6294a90a23a12024-06-24WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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