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 8 of 9 · 179 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFOLXACINBryant Ranch Prepackc9108da9-c271-4e9e-a035-8dd3019e8cf32024-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFOLXACINBryant Ranch Prepack2b8288a2-18bf-423c-b175-33174be729d42024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.44e5582d-fff1-0ec9-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.46dedf2c-26de-0f46-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
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
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.b064286b-fedc-be68-e053-2995a90aae522024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.54c73290-bd89-3453-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7def5a45-6725-0521-e053-2991aa0a0bda2024-06-12Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7d533171-0879-3854-e053-2a91aa0a3b462024-06-12Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.641729a3-6dd3-3a2f-e053-2991aa0a015e2024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.5bab9397-b9f3-d309-e053-2991aa0a66122024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309309
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPec337816-4f48-4d04-b91d-60f9f5f634da2024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077859
rxcui: 309309
unii: 4BA73M5E37
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONEDr. Reddy's Laboratories, Inc.f07cf7d6-c233-884e-342d-c6c8cd2c84382024-05-30Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINLeading Pharma, LLC545527e7-05c7-4dbf-ab32-b3fa463d55b02024-05-10Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINBryant Ranch Prepack4f600112-168a-4a58-9914-7c01f71894da2024-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197511
unii: 4BA73M5E37
CiprofloxacinCIPROFLOXACINBryant Ranch Prepacka57066d7-dc2c-d2d0-b003-d9143fcca1c52024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197512
unii: 4BA73M5E37
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsab640d62-f470-4b50-818f-0c0a339047432023-11-21Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONEARMAS PHARMACEUTICALS INC.eed6b293-6bbe-4bd3-ad9d-3849e0eb6c052023-11-17Warnings, Adverse reactionsExact identifier
unii: 4BA73M5E37
ciprofloxacinCIPROFLOXACINA-S Medication Solutions6971a958-08f0-4712-bf5f-47fe4f76b8632023-11-13Boxed 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.