ciprofloxacin hcl ophthalmic

Generic: ciprofloxacin hydrochloride

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

Drug Facts

Product Profile

Brand Name ciprofloxacin hcl ophthalmic
Generic Name ciprofloxacin hydrochloride
Labeler altaire pharmaceuticals inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL

Manufacturer
Altaire Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59390-217
Product ID 59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204613
Listing Expiration 2026-12-31
Marketing Start 2018-05-04

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59390217
Hyphenated Format 59390-217

Supplemental Identifiers

RxCUI
309307
UPC
4776638217054
UNII
4BA73M5E37

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 hcl ophthalmic (source: ndc)
Generic Name ciprofloxacin hydrochloride (source: ndc)
Application Number ANDA204613 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 2.5 mL in 1 BOTTLE, PLASTIC (59390-217-02)
  • 5 mL in 1 BOTTLE, PLASTIC (59390-217-05)
  • 10 mL in 1 BOTTLE, PLASTIC (59390-217-10)
source: ndc

Packages (3)

59390-217-02 2.5 mL in 1 BOTTLE, PLASTIC (59390-217-02) 59390-217-05 5 mL in 1 BOTTLE, PLASTIC (59390-217-05) 59390-217-10 10 mL in 1 BOTTLE, PLASTIC (59390-217-10)

Ingredients (1)

ciprofloxacin hydrochloride (3 mg/mL)

Linked Drug Pages (1)

Ciprofloxacin HCl Ophthalmic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "f31149b7-60fc-4cef-8270-5eb8ff2b42bb", "openfda": {"upc": ["4776638217054"], "unii": ["4BA73M5E37"], "rxcui": ["309307"], "spl_set_id": ["41363a06-d6f5-4bc6-b0e9-34e5616ae387"], "manufacturer_name": ["Altaire Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 BOTTLE, PLASTIC (59390-217-02)", "package_ndc": "59390-217-02", "marketing_start_date": "20180504"}, {"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (59390-217-05)", "package_ndc": "59390-217-05", "marketing_start_date": "20180504"}, {"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (59390-217-10)", "package_ndc": "59390-217-10", "marketing_start_date": "20180504"}], "brand_name": "Ciprofloxacin HCl Ophthalmic", "product_id": "59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bb", "dosage_form": "SOLUTION", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "59390-217", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Altaire Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin HCl Ophthalmic", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}], "application_number": "ANDA204613", "marketing_category": "ANDA", "marketing_start_date": "20180504", "listing_expiration_date": "20261231"}