ofloxacin

Generic: ofloxacin otic

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

Drug Facts

Product Profile

Brand Name ofloxacin
Generic Name ofloxacin otic
Labeler northstar rxllc
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

ofloxacin 3 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-186
Product ID 72603-186_1831737e-5035-4daf-9924-5a29ebb6b433
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216130
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 72603186
Hyphenated Format 72603-186

Supplemental Identifiers

RxCUI
242446
UPC
0372603186017 0372603186024
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 otic (source: ndc)
Application Number ANDA216130 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, DROPPER (72603-186-01)
  • 10 mL in 1 BOTTLE, DROPPER (72603-186-02)
source: ndc

Packages (2)

72603-186-01 5 mL in 1 BOTTLE, DROPPER (72603-186-01) 72603-186-02 10 mL in 1 BOTTLE, DROPPER (72603-186-02)

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": ["AURICULAR (OTIC)"], "spl_id": "1831737e-5035-4daf-9924-5a29ebb6b433", "openfda": {"nui": ["N0000175937", "M0023650"], "upc": ["0372603186017", "0372603186024"], "unii": ["A4P49JAZ9H"], "rxcui": ["242446"], "spl_set_id": ["b95114f6-6753-4217-b621-44fa34afc298"], "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 (72603-186-01)", "package_ndc": "72603-186-01", "marketing_start_date": "20231201"}, {"sample": false, "description": "10 mL in 1 BOTTLE, DROPPER (72603-186-02)", "package_ndc": "72603-186-02", "marketing_start_date": "20231201"}], "brand_name": "ofloxacin", "product_id": "72603-186_1831737e-5035-4daf-9924-5a29ebb6b433", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "72603-186", "generic_name": "ofloxacin otic", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ofloxacin", "active_ingredients": [{"name": "OFLOXACIN", "strength": "3 mg/mL"}], "application_number": "ANDA216130", "marketing_category": "ANDA", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}