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 87 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Sodium ChlorideSODIUM CHLORIDECODAN US CORPORATIONaa06e286-75c6-4d7a-959f-6008d38aa6e52024-06-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Nuvik Large Roll in Bucket Antibacterial Hand WipesBENZALKONIUM CHLORIDENuvik Usa, Inc.1f2035a1-0b8a-435e-a5ef-6ceda863fd372024-06-18WarningsExact identifier
unii: F5UM2KM3W7
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
unii: F5UM2KM3W7
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
OCUFLOXOFLOXACINAllergan, Inc.7aab4449-3dda-4e2c-8e40-b3244a548bf52024-06-13Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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