FDA.reportPublic FDA data

NDC 55545-1011-2 - 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
55545-1011-2
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 70 of 72 · 1,440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: QTT17582CB
Aceticum acidumACETIC ACIDBoiron69214a87-0b8c-702d-e053-2a91aa0a34162023-07-03Exact identifier
unii: Q40Q9N063P
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepack8eef4f14-e7ef-41be-be57-7993b333e8a92023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
TOUCH Sanitizing Germ Block, Unscented, 1oz (28.35g)BENZALKONIUM CHLORIDERelevo, Inc.c3ba1f21-51d9-c4ee-e053-2995a90aa0422023-05-16WarningsExact identifier
unii: F5UM2KM3W7
DysBio PlusECHINACEA (ANGUSTIFOLIA), ALOE, COLCHICUM AUTUMNALE, COLOCYNTHIS, MERCURIUS CORROSIVUS, NUX VOMICA, ARSENICUM ALBUM, ACETICUM ACIDUM, CHININUM SULPHURICUM, CHOLERA NOSODE, PROTEUS (VULGARIS), COLIBACILLINUM CUM NATRUM MURIATICUM, HELICOBACTER PYLORI, BOTULINUM, SALMONELLA TYPHI NOSODE, MORGAN GAERTNER, CLOSTRIDIUM DIFFICILE, BRUGIA MALAYIDeseret Biologicals, Inc.4dcb84ac-48a4-4e09-a6ff-9748218149002023-04-20WarningsExact identifier
unii: Q40Q9N063P
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MEZEREUM, URANIUM NITRICUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.a13a91e0-572a-4f9c-b80e-f161f055e6fd2023-04-10WarningsExact identifier
unii: Q40Q9N063P
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
Zylast Antiseptic KBENZALKONIUM CHLORIDEInnovative Biodefense84766b3b-915c-b604-e053-2a91aa0a672c2023-01-01WarningsExact identifier
unii: F5UM2KM3W7
CiprofloxacinCIPROFLOXACINProficient Rx LP6b5fe0aa-c74f-42f3-a84a-1cb16009aa802023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPe04dfddd-6177-4c2e-8f42-acd65848e6e22022-12-01Warnings, Adverse reactionsExact identifier
rxcui: 309307
unii: 4BA73M5E37
Ciprofloxacin HCl OphthalmicCIPROFLOXACIN HYDROCHLORIDEAltaire Pharmaceuticals Inc.41363a06-d6f5-4bc6-b0e9-34e5616ae3872022-10-28Warnings, Adverse reactionsExact identifier
rxcui: 309307
unii: 4BA73M5E37
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONEAmneal Pharmaceuticals of New York LLC55426495-5fd1-44ca-afcc-ffbbb0a0a5692022-10-26Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINPharmPak, Inc.e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINPharmPak, Inc.6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEAsclemed USA, Inc.eafad445-2735-434b-a1c6-e1c6b201d2cf2022-09-07Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CVS PharmacyBENZALKONIUM CHLORIDECVS Pharmacy Ince78ad7c1-23ab-6fec-e053-2995a90a16c02022-08-15WarningsExact identifier
unii: F5UM2KM3W7
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPa093ca6e-9963-4eea-b60d-6e2f148192ec2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LP9ee1f252-a64e-4b72-a6f7-60298e8272222022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINProficient Rx LPfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc452022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37

Reported adverse events (FAERS/openFDA)#

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