zymaxid

Generic: gatifloxacin

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zymaxid
Generic Name gatifloxacin
Labeler allergan, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gatifloxacin 5 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-3615
Product ID 0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022548
Listing Expiration 2026-12-31
Marketing Start 2010-05-19

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00233615
Hyphenated Format 0023-3615

Supplemental Identifiers

RxCUI
992395 992399
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 zymaxid (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 (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

0023-3615-01 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPER 0023-3615-25 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

gatifloxacin (5 mg/mL)

Linked Drug Pages (1)

ZYMAXID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "8ecbdc67-bc68-4437-b99d-9924e25dfe67", "openfda": {"unii": ["L4618BD7KJ"], "rxcui": ["992395", "992399"], "spl_set_id": ["1160b16c-929a-4e85-9c0b-1d8c96a7678b"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01)  / 1 mL in 1 BOTTLE, DROPPER", "package_ndc": "0023-3615-01", "marketing_start_date": "20100519"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0023-3615-25", "marketing_start_date": "20100519"}], "brand_name": "ZYMAXID", "product_id": "0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "0023-3615", "generic_name": "gatifloxacin", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYMAXID", "active_ingredients": [{"name": "GATIFLOXACIN", "strength": "5 mg/mL"}], "application_number": "NDA022548", "marketing_category": "NDA", "marketing_start_date": "20100519", "listing_expiration_date": "20261231"}