moxifloxacin ophthalmic solution

Generic: moxifloxacin

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name moxifloxacin ophthalmic solution
Generic Name moxifloxacin
Labeler lifestar pharma llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

moxifloxacin hydrochloride 5 mg/mL

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-638
Product ID 70756-638_22d5cd84-26c0-49b0-afbf-1e9155749cf6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217988
Listing Expiration 2026-12-31
Marketing Start 2025-01-27

Pharmacologic Class

Classes
fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70756638
Hyphenated Format 70756-638

Supplemental Identifiers

RxCUI
403818
UPC
0370756638254
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 (source: ndc)
Application Number ANDA217988 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70756-638-25) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

70756-638-25 1 BOTTLE in 1 CARTON (70756-638-25) / 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": "22d5cd84-26c0-49b0-afbf-1e9155749cf6", "openfda": {"upc": ["0370756638254"], "unii": ["C53598599T"], "rxcui": ["403818"], "spl_set_id": ["ca19b837-8e80-408f-af7b-b0464f20c0c3"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70756-638-25)  / 3 mL in 1 BOTTLE", "package_ndc": "70756-638-25", "marketing_start_date": "20250127"}], "brand_name": "Moxifloxacin ophthalmic solution", "product_id": "70756-638_22d5cd84-26c0-49b0-afbf-1e9155749cf6", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "70756-638", "generic_name": "Moxifloxacin", "labeler_name": "Lifestar Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Moxifloxacin ophthalmic solution", "active_ingredients": [{"name": "MOXIFLOXACIN HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA217988", "marketing_category": "ANDA", "marketing_start_date": "20250127", "listing_expiration_date": "20261231"}