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 29 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Covex Antibacterial Bar Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae1-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Bar Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc18f329-eae5-6ea1-e053-2a95a90a96362026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Active ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e0-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Hand Wash Fresh ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19269c-cd28-f12f-e053-2a95a90ab0162026-01-22WarningsExact identifier
unii: F5UM2KM3W7
Covex Antibacterial Liquid Hand Wash Cool ProtectionBENZALKONIUM CHLORIDEDALAN KIMYA ENDUSTRI ANONIM SIRKETIbc19157f-b1e2-1142-e053-2a95a90a2ceb2026-01-22WarningsExact identifier
unii: F5UM2KM3W7
BZK AntisepticBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.698ed472-9204-46e3-95a4-d59e204628ac2026-01-21WarningsExact identifier
unii: F5UM2KM3W7
LIGHTS SwabstickBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.9346512e-53a1-420a-8b4d-bfbec32576a22026-01-21WarningsExact identifier
unii: F5UM2KM3W7
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution48d73434-e65b-dc98-e063-6294a90affa22026-01-20Adverse reactionsExact identifier
unii: 451W47IQ8X
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
OfloxacinOFLOXACINPreferred Pharmaceuticals Inc.f7916bb3-7593-45f8-b9de-98e0f2d572272026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Walgreens Antibacterial Hand WipesBENZALKONIUM CHLORIDEWalgreen Co.61aed8f1-ddf6-41d0-9d12-8affc43265d62026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3afde78-b9f6-3648-e053-2a95a90a40242026-01-15WarningsExact identifier
unii: F5UM2KM3W7
Caring HandsHAND MOISTURIZING SANITIZERGleeco Labs LLC2ced5dc5-47dd-1b71-e063-6394a90a0e3d2026-01-14WarningsExact identifier
unii: F5UM2KM3W7
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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