moxifloxacin

Generic: moxifloxacin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin
Generic Name moxifloxacin
Labeler proficient rx lp
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-055
Product ID 82804-055_c38e051f-5765-4066-9953-2d0832481b1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206242
Listing Expiration 2026-12-31
Marketing Start 2017-10-04

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804055
Hyphenated Format 82804-055

Supplemental Identifiers

RxCUI
403818
UPC
0382804055036
UNII
C53598599T

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 ANDA206242 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (82804-055-03) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

82804-055-03 1 BOTTLE in 1 CARTON (82804-055-03) / 3 mL in 1 BOTTLE

Ingredients (1)

moxifloxacin hydrochloride (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": "c38e051f-5765-4066-9953-2d0832481b1e", "openfda": {"upc": ["0382804055036"], "unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["c38e051f-5765-4066-9953-2d0832481b1e"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (82804-055-03)  / 3 mL in 1 BOTTLE", "package_ndc": "82804-055-03", "marketing_start_date": "20240109"}], "brand_name": "MOXIFLOXACIN", "product_id": "82804-055_c38e051f-5765-4066-9953-2d0832481b1e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "82804-055", "generic_name": "MOXIFLOXACIN", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOXIFLOXACIN", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA206242", "marketing_category": "ANDA", "marketing_start_date": "20171004", "listing_expiration_date": "20261231"}