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 3 of 9 · 179 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.78641acd-eedf-4b68-bb18-da0874415f592026-03-27Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINPreferred Pharmaceuticals Inc.18414c5a-8153-44f7-b27a-90c290af0a232026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.c2d8dcc9-23b0-75bb-e053-2995a90a02c82026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.3b9b15f7-354b-4049-982b-f6f31751a8852026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONENuCare Pharmaceutical, Inc.4d650d9d-a98a-2dbe-e063-6294a90a00772026-03-19Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINDirect_Rx351b41db-622f-a1eb-e063-6294a90a56672026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CIPROFLOXACINCIPROFLOXACIN HYDROCHLORIDEDIRECT RXa7e5174a-dd01-6050-e053-2a95a90add3f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf52e242-199b-4206-e053-2a95a90a1eb72026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf8d4359-a850-97b7-e053-2a95a90aa66a2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINMajor Pharmaceuticalsf818ed31-c746-4171-afdf-57a75434e5f12026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiproCIPROFLOXACIN HYDROCHLORIDEBayer HealthCare Pharmaceuticals Inc.888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c02026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
rxcui: 197511
unii: 4BA73M5E37
Ciprofloxacin and DexamethasoneCIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONEUpsher-Smith Laboratories, LLC9c5994d1-01d1-493c-a6ae-94754cd593892026-02-13Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINSportpharm LLC190395a8-c05f-4e31-9a89-7af6428ebbb92026-02-05Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDERedpharm Drug4972e902-e042-e947-e063-6394a90a1b702026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINDirect_Rx36d6c27d-45dc-3081-e063-6394a90a87e92026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINPreferred Pharmaceuticals, Inc.85c48ebc-d94a-4254-86df-d2c1aff09b372026-01-13Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions1057be77-00bb-4839-be3d-c8e11ae531a22026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions6d029ad2-a1e8-4c11-a5eb-e2257c6a0ddb2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENorthwind Health Company, LLC2f123a2c-3f94-ca2d-e063-6394a90aff682026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENorthwind Health Company, LLCf80ab01d-2533-1b4c-e053-6294a90a6e6a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37

Reported adverse events (FAERS/openFDA)#

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