moxifloxacin ophthalmic solution

Generic: moxifloxacin ophthalmic solution

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin ophthalmic solution
Generic Name moxifloxacin ophthalmic solution
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-505
Product ID 46708-505_09d80c83-4b62-47a1-a3d7-6352bc6a79cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209469
Listing Expiration 2026-12-31
Marketing Start 2019-02-13

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708505
Hyphenated Format 46708-505

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 solution (source: ndc)
Application Number ANDA209469 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-505-03) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

46708-505-03 1 BOTTLE in 1 CARTON (46708-505-03) / 3 mL in 1 BOTTLE

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": "09d80c83-4b62-47a1-a3d7-6352bc6a79cd", "openfda": {"unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["fee8323d-bcb0-4f49-a06d-2ed597a7b2ac"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-505-03)  / 3 mL in 1 BOTTLE", "package_ndc": "46708-505-03", "marketing_start_date": "20190213"}], "brand_name": "Moxifloxacin ophthalmic solution", "product_id": "46708-505_09d80c83-4b62-47a1-a3d7-6352bc6a79cd", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "46708-505", "generic_name": "Moxifloxacin ophthalmic solution", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin ophthalmic solution", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA209469", "marketing_category": "ANDA", "marketing_start_date": "20190213", "listing_expiration_date": "20261231"}