ofloxacin

Generic: ofloxacin

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin
Labeler northstar rxllc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-192
Product ID 72603-192_223e63df-93af-49f0-86ae-dd4d7042f96a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215886
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603192
Hyphenated Format 72603-192

Supplemental Identifiers

RxCUI
312075
UPC
0372603192018
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 ANDA215886 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (72603-192-01)
  • 10 mL in 1 BOTTLE, DROPPER (72603-192-02)
source: ndc

Packages (2)

72603-192-01 5 mL in 1 BOTTLE, DROPPER (72603-192-01) 72603-192-02 10 mL in 1 BOTTLE, DROPPER (72603-192-02)

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": "223e63df-93af-49f0-86ae-dd4d7042f96a", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0372603192018"], "unii": ["A4P49JAZ9H"], "rxcui": ["312075"], "spl_set_id": ["7c98c671-aefa-48c3-971a-001f16aa72a8"], "pharm_class_cs": ["Quinolones [CS]"], "pharm_class_epc": ["Quinolone Antimicrobial [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (72603-192-01)", "package_ndc": "72603-192-01", "marketing_start_date": "20231201"}, {"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (72603-192-02)", "package_ndc": "72603-192-02", "marketing_start_date": "20241001"}], "brand_name": "ofloxacin", "product_id": "72603-192_223e63df-93af-49f0-86ae-dd4d7042f96a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "72603-192", "generic_name": "ofloxacin", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA215886", "marketing_category": "ANDA", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}