ocuflox

Generic: ofloxacin

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

Drug Facts

Product Profile

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

ofloxacin 3 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 11980-779
Product ID 11980-779_4ba88457-b1b2-4bbc-b086-a2bab56752a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019921
Listing Expiration 2026-12-31
Marketing Start 1993-08-01

Pharmacologic Class

Established (EPC)
quinolone antimicrobial [epc]
Chemical Structure
quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11980779
Hyphenated Format 11980-779

Supplemental Identifiers

RxCUI
207202 312075
UNII
A4P49JAZ9H
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 ocuflox (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number NDA019921 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

11980-779-05 1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

OCUFLOX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4ba88457-b1b2-4bbc-b086-a2bab56752a0", "openfda": {"nui": ["N0000175937", "M0023650"], "unii": ["A4P49JAZ9H"], "rxcui": ["207202", "312075"], "spl_set_id": ["7aab4449-3dda-4e2c-8e40-b3244a548bf5"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (11980-779-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "11980-779-05", "marketing_start_date": "19930801"}], "brand_name": "OCUFLOX", "product_id": "11980-779_4ba88457-b1b2-4bbc-b086-a2bab56752a0", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "11980-779", "generic_name": "ofloxacin", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OCUFLOX", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "NDA019921", "marketing_category": "NDA", "marketing_start_date": "19930801", "listing_expiration_date": "20261231"}