gatifloxacin ophthalmic solution 0.5%

Generic: gatifloxacin ophthalmic solution 0.5%

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gatifloxacin ophthalmic solution 0.5%
Generic Name gatifloxacin ophthalmic solution 0.5%
Labeler caplin steriles limited
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

gatifloxacin anhydrous 5 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-207
Product ID 65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213542
Listing Expiration 2026-12-31
Marketing Start 2025-10-06

Pharmacologic Class

Established (EPC)
quinolone antimicrobial [epc]
Chemical Structure
quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145207
Hyphenated Format 65145-207

Supplemental Identifiers

RxCUI
992395
UPC
0365145207012
UNII
81485Y3A9A
NUI
N0000175937 M0023650

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 gatifloxacin ophthalmic solution 0.5% (source: ndc)
Generic Name gatifloxacin ophthalmic solution 0.5% (source: ndc)
Application Number ANDA213542 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE
source: ndc

Packages (1)

65145-207-01 1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE

Ingredients (1)

gatifloxacin anhydrous (5 mg/mL)

Linked Drug Pages (1)

Gatifloxacin Ophthalmic Solution 0.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0365145207012"], "unii": ["81485Y3A9A"], "rxcui": ["992395"], "spl_set_id": ["2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65145-207-01)  / 2.5 mL in 1 BOTTLE", "package_ndc": "65145-207-01", "marketing_start_date": "20251006"}], "brand_name": "Gatifloxacin Ophthalmic Solution 0.5%", "product_id": "65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "65145-207", "generic_name": "Gatifloxacin Ophthalmic Solution 0.5%", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gatifloxacin Ophthalmic Solution 0.5%", "active_ingredients": [{"name": "GATIFLOXACIN ANHYDROUS", "strength": "5 mg/mL"}], "application_number": "ANDA213542", "marketing_category": "ANDA", "marketing_start_date": "20251006", "listing_expiration_date": "20261231"}