ciprofloxacin otic

Generic: ciprofloxacin

Labeler: genus lifesciences
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin otic
Generic Name ciprofloxacin
Labeler genus lifesciences
Dosage Form SOLUTION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

ciprofloxacin .5 mg/.25mL

Manufacturer
Genus Lifesciences

Identifiers & Regulatory

Product NDC 64950-381
Product ID 64950-381_3f726b10-ef7b-47d6-96c9-e1a7ee5461d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217887
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

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 64950381
Hyphenated Format 64950-381

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 (source: ndc)
Generic Name ciprofloxacin (source: ndc)
Application Number ANDA217887 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • .5 mg/.25mL
source: ndc
Packaging
  • 14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL
source: ndc

Packages (1)

64950-381-14 14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL

Ingredients (1)

ciprofloxacin (.5 mg/.25mL)

Linked Drug Pages (1)

Ciprofloxacin Otic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "3f726b10-ef7b-47d6-96c9-e1a7ee5461d9", "openfda": {"nui": ["N0000193223", "M0372253", "N0000182138"], "unii": ["5E8K9I0O4U"], "rxcui": ["848956"], "spl_set_id": ["51dde3f2-adb1-4ed8-83c6-1f63723a2529"], "pharm_class_cs": ["Fluoroquinolones [CS]"], "pharm_class_epc": ["Fluoroquinolone Antibacterial [EPC]"], "pharm_class_moa": ["Cytochrome P450 1A2 Inhibitors [MoA]"], "manufacturer_name": ["Genus Lifesciences"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 VIAL in 1 CARTON (64950-381-14)  / .25 mL in 1 VIAL", "package_ndc": "64950-381-14", "marketing_start_date": "20241201"}], "brand_name": "Ciprofloxacin Otic", "product_id": "64950-381_3f726b10-ef7b-47d6-96c9-e1a7ee5461d9", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "64950-381", "generic_name": "Ciprofloxacin", "labeler_name": "Genus Lifesciences", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin Otic", "active_ingredients": [{"name": "CIPROFLOXACIN", "strength": ".5 mg/.25mL"}], "application_number": "ANDA217887", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}