vigamox

Generic: moxifloxacin hydrochloride

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigamox
Generic Name moxifloxacin hydrochloride
Labeler harrow eye, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-700
Product ID 82667-700_48fbfef1-1e3b-4558-e063-6394a90a2454
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021598
Listing Expiration 2027-12-31
Marketing Start 2024-07-01

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667700
Hyphenated Format 82667-700

Supplemental Identifiers

RxCUI
403818 404473
UNII
C53598599T

Packaging Origin

Original Packager
true

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 vigamox (source: ndc)
Generic Name moxifloxacin hydrochloride (source: ndc)
Application Number NDA021598 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (82667-700-03) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

82667-700-03 1 BOTTLE in 1 CARTON (82667-700-03) / 3 mL in 1 BOTTLE

Ingredients (1)

moxifloxacin hydrochloride (5 mg/mL)

Linked Drug Pages (1)

VIGAMOX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "48fbfef1-1e3b-4558-e063-6394a90a2454", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818", "404473"], "spl_set_id": ["12053b08-7e66-c6f3-e063-6394a90a9cd9"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (82667-700-03)  / 3 mL in 1 BOTTLE", "package_ndc": "82667-700-03", "marketing_start_date": "20240701"}], "brand_name": "VIGAMOX", "product_id": "82667-700_48fbfef1-1e3b-4558-e063-6394a90a2454", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "82667-700", "generic_name": "moxifloxacin hydrochloride", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIGAMOX", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA021598", "marketing_category": "NDA", "marketing_start_date": "20240701", "listing_expiration_date": "20271231"}