FDA.reportPublic FDA data

NDC 68071-2265-01 - 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
68071-2265
Requested NDC
68071-2265-01
Package NDCs from labels
68071-2265-1, 68071-2265-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ofloxacin Ophthalmic Solution 0.3%NuCare Pharmaceuticals,Inc.2024-07-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2265-1Ofloxacin1 in 1 CARTONSOLUTION/ DROPS13
68071-2265-1Ofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2265OFLOXACIN SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240719_af861f20-5ec8-2883-e053-2a95a90a2312.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 79 of 110 · 2,184 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC8fce1477-991f-4b43-bf05-a80bad8972622024-10-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.af08f71c-974e-076b-e053-2995a90afc952024-10-15WarningsExact identifier
unii: F5UM2KM3W7
Genuine First Aid First Aid Antiseptic Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.af08c8f7-8761-ee3f-e053-2995a90a96772024-10-15WarningsExact identifier
unii: F5UM2KM3W7
First Aid Only BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEAcme United Corporationc927f845-1383-ae85-e053-2995a90a12fc2024-10-15WarningsExact identifier
unii: F5UM2KM3W7
First Aid Only BZK AntisepticBENZALKONIUM CHLORIDEAcme United Corporationdbed7ed6-a9b8-7b59-e053-2a95a90ac0cb2024-10-15WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH BLUEBERRIESBENZALKONIUM CHLORIDEUniversal Distribution Center LLC3a1b0112-a400-4cea-9372-c0654e5182672024-10-15WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL HANDWASH TROPICAL BEACHBENZALKONIUM CHLORIDEUniversal Distribution Center LLC747affab-118b-882d-e053-2a91aa0a25642024-10-15WarningsExact identifier
unii: F5UM2KM3W7
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Target Up and Up 2-in-1 Hand SanitizerBENZETHONIUM CHLORIDETARGET CORPORATIONe069c9e6-024d-5482-e053-2995a90a767d2024-10-14WarningsExact identifier
unii: F5UM2KM3W7
OfloxacinOFLOXACINA-S Medication Solutions1838671d-e312-442a-b0bc-6702d6a8965c2024-10-14Warnings, Adverse reactionsExact identifier
application number: ANDA076622
rxcui: 312075
unii: A4P49JAZ9H
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
First Aid Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Changjian Medical Products Co., Ltd.9cb3759a-35d9-4f6b-94ad-fafd4bc600bd2024-10-11WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic ToweletteBENZALKONIUM CHLORIDEHubei Changjian Medical Products Co., Ltd.bf045881-9636-4000-a0ac-f6aab6b818322024-10-11WarningsExact identifier
unii: F5UM2KM3W7
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
McKesson Obstetrical Antiseptic ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgical51a3dabe-25d3-47fd-b640-83e68f7e06de2024-10-11WarningsExact identifier
unii: F5UM2KM3W7
McKesson Benzalkonium Chloride ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgicalcea36a9e-aac3-4494-a713-1dc64272d99c2024-10-11WarningsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc44b0fdb-33df-4747-b443-5fb4deb456cb2024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCe5e325d1-0d58-40c9-9645-3ae402ff9d922024-10-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
OfloxacinOFLOXACINSomerset Therapeutics, LLC4b2b893d-c19b-4c4a-85de-ff901325080b2024-10-11Warnings, Adverse reactionsExact identifier
rxcui: 312075
unii: A4P49JAZ9H
Vamousse Lice DefenseEUCALYPTUS GLOBULUS, NATRUM MURIATICUMAlliance Pharma Inc.c87ce5d3-c200-421e-88be-bc8060a5993a2024-10-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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