gatifloxacin

Generic: gatifloxacin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gatifloxacin
Generic Name gatifloxacin
Labeler sandoz inc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gatifloxacin 5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-672
Product ID 61314-672_20dfbbfa-5c67-4ac4-a90a-a7dd29395e71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204227
Listing Expiration 2026-12-31
Marketing Start 2016-10-03

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314672
Hyphenated Format 61314-672

Supplemental Identifiers

RxCUI
992395
UNII
L4618BD7KJ

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 ANDA204227 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

61314-672-25 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 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": "20dfbbfa-5c67-4ac4-a90a-a7dd29395e71", "openfda": {"unii": ["L4618BD7KJ"], "rxcui": ["992395"], "spl_set_id": ["9e6fcd14-1fee-493f-811c-e18cbfbee65b"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (61314-672-25)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "61314-672-25", "marketing_start_date": "20161003"}], "brand_name": "Gatifloxacin", "product_id": "61314-672_20dfbbfa-5c67-4ac4-a90a-a7dd29395e71", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "61314-672", "generic_name": "gatifloxacin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gatifloxacin", "active_ingredients": [{"name": "GATIFLOXACIN", "strength": "5 mg/mL"}], "application_number": "ANDA204227", "marketing_category": "ANDA", "marketing_start_date": "20161003", "listing_expiration_date": "20261231"}