Package 65145-207-01

Brand: gatifloxacin ophthalmic solution 0.5%

Generic: gatifloxacin ophthalmic solution 0.5%
NDC Package

Package Facts

Identity

Package NDC 65145-207-01
Digits Only 6514520701
Product NDC 65145-207
Description

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

Marketing

Marketing Status
Marketed Since 2025-10-06
Brand gatifloxacin ophthalmic solution 0.5%
Generic gatifloxacin ophthalmic solution 0.5%
Sample Package No

Linked Drug Pages (1)

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"}