FDA.reportPublic FDA data

NDC 80425-0192-01 - Ciprofloxacin HCL

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
80425-0192
Requested NDC
80425-0192-01
Package NDCs from labels
80425-0192-1, 80425-0192-2, 80425-0192-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2026-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ciprofloxacin HCL - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2026-04-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0192-1Ciprofloxacin HCL20 in 1 BOTTLETABLET, FILM COATED205
80425-0192-2Ciprofloxacin HCL30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0192CIPROFLOXACIN HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]4Current NDC, Legacy NDC, 2 package rows20250101_e237dd23-faf3-1765-e053-2a95a90ae62d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0192-1EA - Each80425-0192420e6287-e716-43fa-84d5-1f18fb3ec1f112023-03-13
80425-0192-2EA - Each80425-0192a76a8bc0-0731-475b-84dc-03d6d2b9f54112023-03-13

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 5 of 9 · 179 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac87e3c7-1e51-4dd1-8b75-dec6536810e32025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFOLXACINPD-Rx Pharmaceuticals, Inc.3b3c0874-90b7-deda-e063-6394a90a78022025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackec43739e-7154-45a7-add7-bfb8fb779be82025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 197512
unii: 4BA73M5E37
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsd2c40b07-dc39-46c6-8ea1-b288589a46d12025-08-18Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3c611c8c-deed-4904-93f7-f75a2147fbf72025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited7041828f-d4ec-4813-bcac-cb335c6c312a2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
rxcui: 197511
rxcui: 197512
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited2b3b6a9f-259c-4736-b88f-f49d1eb642862025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
ndc (product): 65862-077
rxcui: 309309
rxcui: 197511
rxcui: 197512
spl id: 9e7eb1ac-3e09-4b4c-8ce1-ab16c3102a10
spl set id: 2b3b6a9f-259c-4736-b88f-f49d1eb64286
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINRising Pharma Holdings, Inc.ef468722-68cd-440b-afd7-2285029db41f2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
rxcui: 197511
rxcui: 197512
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.2491e6a9-3415-43b9-b31b-67331f52806a2025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197512
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.e81341c6-0e25-4860-adda-2d3cebe88d622025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.178dc379-e2b8-4b47-9f0c-3fc7fb435c362025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFOLXACINPreferred Pharmaceuticals Inc.15755a35-e29a-47c1-89ab-e6645bb3ade92025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.bb2edaca-6cf2-4100-83f5-8ce142f68e592025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionscc768d3e-a7cc-46a2-ae6d-0f5eb2f054062025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINA-S Medication Solutionsc12b316f-811c-48b6-a320-d314991aa74f2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackd6bd5021-cf56-4c8a-b5a0-bbc8919740af2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepack99918613-7936-47dd-8565-9cd6c0cc22e32025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFOLXACINProficient Rx LP0ce2221d-940f-4c07-ba2e-fccb491f6b9b2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.509b932e-9229-42c0-8a4c-f3257ffdca492025-03-29Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINBryant Ranch Prepack69df48cc-76b6-428e-891a-c25e07d785f82025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37

Reported adverse events (FAERS/openFDA)#

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