moxifloxacin

Generic: moxifloxacin

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

moxifloxacin hydrochloride monohydrate 5 mg/mL

Manufacturer
Direct Rx

Identifiers & Regulatory

Product NDC 72189-321
Product ID 72189-321_2c3d2dfe-0fff-b986-e063-6294a90a84c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202867
Listing Expiration 2026-12-31
Marketing Start 2022-02-07

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189321
Hyphenated Format 72189-321

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
  • 3 mL in 1 BOTTLE (72189-321-05)
source: ndc

Packages (1)

Ingredients (1)

moxifloxacin hydrochloride monohydrate (5 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "2c3d2dfe-0fff-b986-e063-6294a90a84c9", "openfda": {"unii": ["B8956S8609"], "rxcui": ["403818"], "spl_set_id": ["d771e69b-7d9b-13fa-e053-2995a90ac161"], "manufacturer_name": ["Direct Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 BOTTLE (72189-321-05)", "package_ndc": "72189-321-05", "marketing_start_date": "20220207"}], "brand_name": "MOXIFLOXACIN", "product_id": "72189-321_2c3d2dfe-0fff-b986-e063-6294a90a84c9", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "72189-321", "generic_name": "MOXIFLOXACIN", "labeler_name": "Direct Rx", "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": "20220207", "listing_expiration_date": "20261231"}