moxifloxacin ophthalmic solution (68083-210)

Drug Facts

Product Profile

Brand Name moxifloxacin ophthalmic solution

Generic Name moxifloxacin ophthalmic

Labeler gland pharma limited

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer

Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-210

Product ID 68083-210_1762525e-0af9-445f-ab67-00bfa954dc7d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208778

Listing Expiration 2026-12-31

Marketing Start 2020-03-30

Pharmacologic Class

Classes

quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083210

Hyphenated Format 68083-210

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 ophthalmic (source: ndc)

Application Number ANDA208778 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

5 mg/mL

source: ndc

Packaging

1 BOTTLE, PLASTIC in 1 CARTON (68083-210-01) / 3 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

68083-210-01 1 BOTTLE, PLASTIC in 1 CARTON (68083-210-01) / 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": "1762525e-0af9-445f-ab67-00bfa954dc7d", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["95773bca-0791-4bfe-955a-4d2fa4561e01"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68083-210-01)  / 3 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68083-210-01", "marketing_start_date": "20200330"}], "brand_name": "Moxifloxacin Ophthalmic Solution", "product_id": "68083-210_1762525e-0af9-445f-ab67-00bfa954dc7d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "68083-210", "generic_name": "Moxifloxacin Ophthalmic", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin Ophthalmic Solution", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA208778", "marketing_category": "ANDA", "marketing_start_date": "20200330", "listing_expiration_date": "20261231"}