ciprofloxacin hydrochloride

Generic: ciprofloxacin hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin hydrochloride
Generic Name ciprofloxacin hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8198
Product ID 68788-8198_8c34fdc0-0963-42e4-b714-f6a3a2407584
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019992
Listing Expiration 2026-12-31
Marketing Start 2022-05-23

Pharmacologic Class

Classes
cytochrome p450 1a2 inhibitors [moa] fluoroquinolone antibacterial [epc] fluoroquinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888198
Hyphenated Format 68788-8198

Supplemental Identifiers

RxCUI
309307
UNII
4BA73M5E37

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 hydrochloride (source: ndc)
Generic Name ciprofloxacin hydrochloride (source: ndc)
Application Number NDA019992 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (68788-8198-5) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

68788-8198-5 1 BOTTLE, PLASTIC in 1 CARTON (68788-8198-5) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ciprofloxacin hydrochloride (3 mg/mL)

Linked Drug Pages (1)

Ciprofloxacin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "8c34fdc0-0963-42e4-b714-f6a3a2407584", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309307"], "spl_set_id": ["78641acd-eedf-4b68-bb18-da0874415f59"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68788-8198-5)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68788-8198-5", "marketing_start_date": "20220523"}], "brand_name": "Ciprofloxacin Hydrochloride", "product_id": "68788-8198_8c34fdc0-0963-42e4-b714-f6a3a2407584", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "68788-8198", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin Hydrochloride", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}], "application_number": "NDA019992", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220523", "listing_expiration_date": "20261231"}