gatifloxacin

Generic: gatifloxacin

Labeler: Pacific Pharma, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Active

Drug Facts

Product Profile

Brand Name gatifloxacin
Generic Name gatifloxacin
Labeler Pacific Pharma, Inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

GATIFLOXACIN 5 mg/mL

Identifiers & Regulatory

Product NDC 60758-615
Product ID 60758-615_d019efbb-643d-44a1-992e-0222c1abd4d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022548
Listing Expiration 2026-12-31
Marketing Start 2015-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60758615
Hyphenated Format 60758-615

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 NDA022548 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60758-615-25) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

60758-615-25 1 BOTTLE, DROPPER in 1 CARTON (60758-615-25) / 2.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

GATIFLOXACIN (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": "d019efbb-643d-44a1-992e-0222c1abd4d5", "openfda": {"unii": ["L4618BD7KJ"], "rxcui": ["992395"], "spl_set_id": ["3dd6ac6b-877a-46c7-bbc8-c7119f341abe"], "manufacturer_name": ["Pacific Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60758-615-25)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60758-615-25", "marketing_start_date": "20150415"}], "brand_name": "gatifloxacin", "product_id": "60758-615_d019efbb-643d-44a1-992e-0222c1abd4d5", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "60758-615", "generic_name": "gatifloxacin", "labeler_name": "Pacific Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gatifloxacin", "active_ingredients": [{"name": "GATIFLOXACIN", "strength": "5 mg/mL"}], "application_number": "NDA022548", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20150415", "listing_expiration_date": "20261231"}