moxifloxacin

Generic: moxifloxacin

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin
Generic Name moxifloxacin
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride monohydrate 5 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0582
Product ID 60505-0582_1f0760bf-4dfb-6466-23d6-72770eecf10e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090080
Listing Expiration 2026-12-31
Marketing Start 2017-07-01

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050582
Hyphenated Format 60505-0582

Supplemental Identifiers

RxCUI
403818
UNII
B8956S8609

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 moxifloxacin (source: ndc)
Generic Name moxifloxacin (source: ndc)
Application Number ANDA090080 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0582-4) / 3 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

60505-0582-4 1 BOTTLE, DROPPER in 1 CARTON (60505-0582-4) / 3 mL in 1 BOTTLE, DROPPER

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": "1f0760bf-4dfb-6466-23d6-72770eecf10e", "openfda": {"unii": ["B8956S8609"], "rxcui": ["403818"], "spl_set_id": ["8f7a0c4c-34f4-7362-579b-f26c3338f792"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0582-4)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0582-4", "marketing_start_date": "20170701"}], "brand_name": "Moxifloxacin", "product_id": "60505-0582_1f0760bf-4dfb-6466-23d6-72770eecf10e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "60505-0582", "generic_name": "moxifloxacin", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE", "strength": "5 mg/mL"}], "application_number": "ANDA090080", "marketing_category": "ANDA", "marketing_start_date": "20170701", "listing_expiration_date": "20261231"}