gatifloxacin

Generic: gatifloxacin

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

Drug Facts

Product Profile

Brand Name gatifloxacin
Generic Name gatifloxacin
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

gatifloxacin anhydrous 5 mg/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-331
Product ID 69315-331_14b4bf1f-07ed-4578-96ac-47fc9c7c058b
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 69315331
Hyphenated Format 69315-331

Supplemental Identifiers

RxCUI
992395
UPC
0369315331026
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 (source: ndc)
Generic Name gatifloxacin (source: ndc)
Application Number ANDA213542 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 2.5 mL in 1 BOTTLE (69315-331-02)
source: ndc

Packages (1)

69315-331-02 2.5 mL in 1 BOTTLE (69315-331-02)

Ingredients (1)

gatifloxacin anhydrous (5 mg/mL)

Linked Drug Pages (1)

GATIFLOXACIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "14b4bf1f-07ed-4578-96ac-47fc9c7c058b", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0369315331026"], "unii": ["81485Y3A9A"], "rxcui": ["992395"], "spl_set_id": ["826cf8c4-4be5-4614-bd42-47c1d0c9df58"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 BOTTLE (69315-331-02)", "package_ndc": "69315-331-02", "marketing_start_date": "20251006"}], "brand_name": "GATIFLOXACIN", "product_id": "69315-331_14b4bf1f-07ed-4578-96ac-47fc9c7c058b", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "69315-331", "generic_name": "GATIFLOXACIN", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GATIFLOXACIN", "active_ingredients": [{"name": "GATIFLOXACIN ANHYDROUS", "strength": "5 mg/mL"}], "application_number": "ANDA213542", "marketing_category": "ANDA", "marketing_start_date": "20251006", "listing_expiration_date": "20261231"}