moxifloxacin

Generic: moxifloxacin

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin
Generic Name moxifloxacin
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride monohydrate 5 mg/mL

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0379
Product ID 80425-0379_14307586-424f-091a-e063-6394a90aee1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202867
Listing Expiration 2026-12-31
Marketing Start 2024-03-21

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250379
Hyphenated Format 80425-0379

Supplemental Identifiers

RxCUI
403818
UNII
B8956S8609

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name moxifloxacin (source: ndc)
Generic Name moxifloxacin (source: ndc)
Application Number ANDA202867 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (80425-0379-1) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

80425-0379-1 1 BOTTLE in 1 CARTON (80425-0379-1) / 3 mL in 1 BOTTLE

Ingredients (1)

moxifloxacin hydrochloride monohydrate (5 mg/mL)

Linked Drug Pages (1)

Moxifloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "14307586-424f-091a-e063-6394a90aee1f", "openfda": {"unii": ["B8956S8609"], "rxcui": ["403818"], "spl_set_id": ["143075b4-24d4-08a1-e063-6394a90a8a6e"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (80425-0379-1)  / 3 mL in 1 BOTTLE", "package_ndc": "80425-0379-1", "marketing_start_date": "20240321"}], "brand_name": "Moxifloxacin", "product_id": "80425-0379_14307586-424f-091a-e063-6394a90aee1f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "80425-0379", "generic_name": "Moxifloxacin", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE", "strength": "5 mg/mL"}], "application_number": "ANDA202867", "marketing_category": "ANDA", "marketing_start_date": "20240321", "listing_expiration_date": "20261231"}