ciprofloxacin otic solution, 0.2%

Generic: ciprofloxacin otic solution, 0.2%

Labeler: virtus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin otic solution, 0.2%
Generic Name ciprofloxacin otic solution, 0.2%
Labeler virtus pharmaceuticals, llc
Dosage Form SOLUTION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

ciprofloxacin .5 mg/.25mL

Manufacturer
Virtus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69543-457
Product ID 69543-457_2a8c7efc-8725-4a70-8af7-24df4ddd492b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217887
Marketing Start 2024-11-15
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
fluoroquinolone antibacterial [epc]
Mechanism of Action
cytochrome p450 1a2 inhibitors [moa]
Chemical Structure
fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69543457
Hyphenated Format 69543-457

Supplemental Identifiers

RxCUI
848956
UNII
5E8K9I0O4U
NUI
N0000193223 M0372253 N0000182138

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 ciprofloxacin otic solution, 0.2% (source: ndc)
Generic Name ciprofloxacin otic solution, 0.2% (source: ndc)
Application Number ANDA217887 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .5 mg/.25mL
source: ndc
Packaging
  • 14 VIAL, SINGLE-DOSE in 1 CARTON (69543-457-14) / .25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

69543-457-14 14 VIAL, SINGLE-DOSE in 1 CARTON (69543-457-14) / .25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ciprofloxacin (.5 mg/.25mL)

Linked Drug Pages (1)

Ciprofloxacin Otic Solution, 0.2% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "2a8c7efc-8725-4a70-8af7-24df4ddd492b", "openfda": {"nui": ["N0000193223", "M0372253", "N0000182138"], "unii": ["5E8K9I0O4U"], "rxcui": ["848956"], "spl_set_id": ["188df3b3-bb47-404a-88a1-80d141b6d07f"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "pharm_class_moa": ["Cytochrome P450 1A2 Inhibitors [MoA]"], "manufacturer_name": ["Virtus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 VIAL, SINGLE-DOSE in 1 CARTON (69543-457-14)  / .25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69543-457-14", "marketing_end_date": "20260331", "marketing_start_date": "20241115"}], "brand_name": "Ciprofloxacin Otic Solution, 0.2%", "product_id": "69543-457_2a8c7efc-8725-4a70-8af7-24df4ddd492b", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "69543-457", "generic_name": "Ciprofloxacin Otic Solution, 0.2%", "labeler_name": "Virtus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin Otic Solution, 0.2%", "active_ingredients": [{"name": "CIPROFLOXACIN", "strength": ".5 mg/.25mL"}], "application_number": "ANDA217887", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20241115"}