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 5 mg/mL

Manufacturer
Direct Rx

Identifiers & Regulatory

Product NDC 72189-334
Product ID 72189-334_2c3d95a4-32d2-ef3b-e063-6294a90ac144
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202916
Listing Expiration 2026-12-31
Marketing Start 2022-03-08

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189334
Hyphenated Format 72189-334

Supplemental Identifiers

RxCUI
403818
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 ANDA202916 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 3 mL in 1 BOTTLE (72189-334-05)
source: ndc

Packages (1)

72189-334-05 3 mL in 1 BOTTLE (72189-334-05)

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": "2c3d95a4-32d2-ef3b-e063-6294a90ac144", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["d9b6a460-6377-76d0-e053-2995a90a3d05"], "manufacturer_name": ["Direct Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 BOTTLE (72189-334-05)", "package_ndc": "72189-334-05", "marketing_start_date": "20220308"}], "brand_name": "MOXIFLOXACIN", "product_id": "72189-334_2c3d95a4-32d2-ef3b-e063-6294a90ac144", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "72189-334", "generic_name": "MOXIFLOXACIN", "labeler_name": "Direct Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOXIFLOXACIN", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA202916", "marketing_category": "ANDA", "marketing_start_date": "20220308", "listing_expiration_date": "20261231"}