FDA.reportPublic FDA data

NDC 55545-1011-3 - ciprofloxacin

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
55545-1011
Requested NDC
55545-1011-3
Package NDCs from labels
55545-1011-1, 55545-1011-2, 55545-1011-3
Manufacturer
FDC Limited
Effective date
2018-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ciprofloxacin - FDC LimitedFDC Limited2018-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1011-1ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-1ciprofloxacin2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.51
55545-1011-2ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-2ciprofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION51
55545-1011-3ciprofloxacin10 mL in 1 BOTTLE, PLASTICSOLUTION101
55545-1011-3ciprofloxacin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1011CIPROFLOXACIN SOLUTION [FDC LIMITED]1Legacy NDC, 6 package rows20181101_0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc.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 60 of 72 · 1,435 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.6860a80e-9a5f-40e4-bec3-e7386e541f5b2024-07-30WarningsExact identifier
unii: F5UM2KM3W7
CILOXANCIPROFLOXACIN HYDROCHLORIDESandoz Inc09ca5374-2a16-4a95-91b3-70591d78254e2024-07-30Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.b0136d72-0869-2da0-e053-2995a90af70a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.b064286b-fedc-be68-e053-2995a90aae522024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
Acetic AcidACETIC ACIDNuCare Pharmaceuticals,Inc.7470a1ed-bc00-cb52-e053-2a91aa0a5c7d2024-07-15Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.de3b8c33-0d6c-49a9-8243-0d52284770f42024-07-12WarningsExact identifier
unii: F5UM2KM3W7
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.7345c155-b5f2-4d29-b469-1153e103cc892024-07-12WarningsExact identifier
unii: F5UM2KM3W7
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.54c73290-bd89-3453-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
rxcui: 309307
unii: 4BA73M5E37
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
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
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
Three CleansingBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1ab25c0d-e616-30f7-e063-6294a90ad1e42024-06-12WarningsExact identifier
unii: F5UM2KM3W7
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7def5a45-6725-0521-e053-2991aa0a0bda2024-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA077568
rxcui: 309307
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7d533171-0879-3854-e053-2a91aa0a3b462024-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA077568
rxcui: 309307
unii: 4BA73M5E37

Reported adverse events (FAERS/openFDA)#

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