moxifloxacin ophthalmic solution

Generic: moxifloxacin hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin ophthalmic solution
Generic Name moxifloxacin hydrochloride
Labeler sandoz inc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-7135
Product ID 0781-7135_fe09f635-c4f0-4698-8468-d226257b6d58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021598
Listing Expiration 2026-12-31
Marketing Start 2003-05-07

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07817135
Hyphenated Format 0781-7135

Supplemental Identifiers

RxCUI
403818
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 moxifloxacin ophthalmic solution (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, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0781-7135-93 1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

moxifloxacin hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Moxifloxacin Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "fe09f635-c4f0-4698-8468-d226257b6d58", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["fc88791b-24da-48a4-85f5-93a8af3d0b51"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93)  / 3 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0781-7135-93", "marketing_start_date": "20170630"}], "brand_name": "Moxifloxacin Ophthalmic Solution", "product_id": "0781-7135_fe09f635-c4f0-4698-8468-d226257b6d58", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "0781-7135", "generic_name": "moxifloxacin hydrochloride", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin Ophthalmic Solution", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA021598", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20030507", "listing_expiration_date": "20261231"}