ofloxacin

Generic: ofloxacin

Labeler: armas pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler armas pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
ARMAS PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 72485-613
Product ID 72485-613_086cc6db-b800-dc8f-e063-6294a90a4196
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076407
Listing Expiration 2026-12-31
Marketing Start 2023-10-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485613
Hyphenated Format 72485-613

Supplemental Identifiers

RxCUI
312075
UPC
0372485613113
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 ofloxacin (source: ndc)
Generic Name ofloxacin (source: ndc)
Application Number ANDA076407 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-613-10) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-613-11) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

72485-613-10 1 BOTTLE, DROPPER in 1 CARTON (72485-613-10) / 5 mL in 1 BOTTLE, DROPPER 72485-613-11 1 BOTTLE, DROPPER in 1 CARTON (72485-613-11) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ofloxacin (3 mg/mL)

Linked Drug Pages (1)

Ofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "086cc6db-b800-dc8f-e063-6294a90a4196", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0372485613113"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["07ac850b-a983-fc21-e063-6394a90a21b2"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["ARMAS PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-613-10)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-613-10", "marketing_start_date": "20231014"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-613-11)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-613-11", "marketing_start_date": "20231014"}], "brand_name": "Ofloxacin", "product_id": "72485-613_086cc6db-b800-dc8f-e063-6294a90a4196", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "72485-613", "generic_name": "Ofloxacin", "labeler_name": "ARMAS PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA076407", "marketing_category": "ANDA", "marketing_start_date": "20231014", "listing_expiration_date": "20261231"}