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 9 of 9 · 179 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINAsclemed USA, Inc.86c2ba30-9372-4e70-88a2-e6e1da07fa922023-09-02Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepack8eef4f14-e7ef-41be-be57-7993b333e8a92023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINProficient Rx LP6b5fe0aa-c74f-42f3-a84a-1cb16009aa802023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPe04dfddd-6177-4c2e-8f42-acd65848e6e22022-12-01Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
Ciprofloxacin HCl OphthalmicCIPROFLOXACIN HYDROCHLORIDEAltaire Pharmaceuticals Inc.41363a06-d6f5-4bc6-b0e9-34e5616ae3872022-10-28Warnings, Adverse reactionsExact identifier
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
rxcui: 197511
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINPharmPak, Inc.6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEAsclemed USA, Inc.eafad445-2735-434b-a1c6-e1c6b201d2cf2022-09-07Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPa093ca6e-9963-4eea-b60d-6e2f148192ec2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LP9ee1f252-a64e-4b72-a6f7-60298e8272222022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 197511
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINProficient Rx LPfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc452022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
rxcui: 197511
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINProficient Rx LP05b2836d-cd3d-4d7f-970c-66ec2d7886672022-05-02Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINAsclemed USA, Inc.1bb1d26e-fad0-4338-8948-3f095d5817a62022-03-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINProficient Rx LP4af3894a-8945-4b2d-bdf6-a83bbd415b892020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197512
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDESandoz Incab52b14d-345b-47ff-a832-465caddd38012019-07-18Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdf24efa3-c9a0-4f40-92ce-cc71c708931b2018-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e74496f-4dca-4471-be32-c0a14bc627502018-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINAphena Pharma Solutions - Tennessee, LLCc7bc0d20-526c-48ea-b23a-cea9eb7080ff2018-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37

Reported adverse events (FAERS/openFDA)#

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