FDA.reportPublic FDA data

NDC 80425-0239-01 - Moxifloxacin

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
80425-0239
Requested NDC
80425-0239-01
Package NDCs from labels
80425-0239-1, 80425-0239-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Moxifloxacin - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0239-1Moxifloxacin3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS33
80425-0239-1Moxifloxacin1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0239MOXIFLOXACIN SOLUTION/ DROPS [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 2 package rows20250102_f19fa89e-9f5d-4eed-e053-2995a90ac3ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0239-1ML - Milliliter80425-0239b22cdef2-08d4-45f9-aadc-dfc84bca01b712023-06-06

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 1 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moxifloxacin Hydrochloride Tablets, 400 mgMOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MGREMEDYREPACK INC.bdb3f89a-01e7-411d-b071-48e87def08732026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: B8956S8609
MOXIFLOXACINMOXIFLOXACINA-S Medication Solutionsf702e112-b037-4e50-ac30-b1d27fc0e30e2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 403818
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERedpharm Drug51d45346-5506-d2c9-e063-6394a90ae6bb2026-05-15Warnings, Adverse reactionsExact identifier
rxcui: 403818
Moxifloxacin ophthalmic solutionMOXIFLOXACINRedpharm Drug4fb55f17-d9db-8148-e063-6394a90a82162026-04-18Warnings, Adverse reactionsExact identifier
rxcui: 403818
VIGAMOXMOXIFLOXACIN HYDROCHLORIDEHarrow Eye, LLC12053b08-7e66-c6f3-e063-6394a90a9cd92026-01-22Warnings, Adverse reactionsExact identifier
rxcui: 403818
MoxifloxacinMOXIFLOXACINRedpharm Drug301eef74-16db-14aa-e063-6294a90ac8ff2025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 403818
unii: B8956S8609
MoxifloxacinMOXIFLOXACINGolden State Medical Supply, Inc.f9dff08a-edb2-86de-e053-6394a90a10432025-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA090080
rxcui: 403818
unii: B8956S8609
MOXIFLOXACINMOXIFLOXACINLupin Pharmaceuticals, Inc.d66f080b-da56-4473-8785-920d9700f72d2025-10-13Warnings, Adverse reactionsExact identifier
rxcui: 403818
MoxifloxacinMOXIFLOXACINLupin Pharmaceuticals, Inc.ae77e219-8af9-4aa4-96d3-05c9726a1d3c2025-10-13Warnings, Adverse reactionsExact identifier
rxcui: 403818
unii: B8956S8609
Moxifloxacin Hydrochloride Tablets, 400 mgMOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MGPD-Rx Pharmaceuticals, Inc.5c2a9116-d6e4-429e-88bb-bb6bfedac2f02025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: B8956S8609
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.8f92f110-32d6-4d0c-a415-7a9a4cafb9b82025-04-19Warnings, Adverse reactionsExact identifier
rxcui: 403818
STRENZA PLUSMOXIFLOXACIN 0.5%, BROMFENAC 0.09%, PREDNISOLONE ACETATE 1%Brisk Pharmaceuticals2df9064c-0527-4c21-e063-6294a90a56d82025-02-12Exact identifier
rxcui: 403818
Moxifloxacin ophthalmic solutionMOXIFLOXACINLifestar Pharma LLCca19b837-8e80-408f-af7b-b0464f20c0c32025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 403818
MOXIFLOXACINMOXIFLOXACINDirect Rxd771e69b-7d9b-13fa-e053-2995a90ac1612025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 403818
unii: B8956S8609
MOXIFLOXACINMOXIFLOXACINDirect Rxd9b6a460-6377-76d0-e053-2995a90a3d052025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 403818
MoxifloxacinMOXIFLOXACINAdvanced Rx Pharmacy of Tennessee, LLCf19fa89e-9f5d-4eed-e053-2995a90ac3ce2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA090080
ndc (package): 80425-0239-1
ndc (product): 80425-0239
ndc11 (package): 80425023901
rxcui: 403818
spl id: 2a9aa671-d0a2-2254-e063-6294a90a9f79
spl set id: f19fa89e-9f5d-4eed-e053-2995a90ac3ce
unii: B8956S8609
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDESomerset Therapeutics, LLCf7c68d49-8c61-4bde-a880-4d78568e5aa02024-11-25Warnings, Adverse reactionsExact identifier
rxcui: 403818
MoxifloxacinMOXIFLOXACINBryant Ranch Prepack1cc031d7-0766-41c0-b5b3-35119c850e232024-10-04Warnings, Adverse reactionsExact identifier
application number: ANDA090080
rxcui: 403818
unii: B8956S8609
Moxifloxacin ophthalmic solutionMOXIFLOXACIN OPHTHALMIC SOLUTIONAlembic Pharmaceuticals Limitedfee8323d-bcb0-4f49-a06d-2ed597a7b2ac2024-04-19Warnings, Adverse reactionsExact identifier
rxcui: 403818
Moxifloxacin ophthalmic solutionMOXIFLOXACIN OPHTHALMIC SOLUTIONAlembic Pharmaceuticals Inc.0f2cdbf6-bc74-4b22-b795-23ace89894b32024-04-19Warnings, Adverse reactionsExact identifier
rxcui: 403818

Reported adverse events (FAERS/openFDA)#

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