ciprofloxacin

Generic: ciprofloxacin

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler asclemed usa, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-588
Product ID 76420-588_045968a3-3bad-28cf-e063-6394a90a4fe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077568
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

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 76420588
Hyphenated Format 76420-588

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 (source: ndc)
Generic Name ciprofloxacin (source: ndc)
Application Number ANDA077568 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (76420-588-02) / 2.5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (76420-588-05) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (76420-588-10) / 10 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

76420-588-02 1 BOTTLE, PLASTIC in 1 CARTON (76420-588-02) / 2.5 mL in 1 BOTTLE, PLASTIC 76420-588-05 1 BOTTLE, PLASTIC in 1 CARTON (76420-588-05) / 5 mL in 1 BOTTLE, PLASTIC 76420-588-10 1 BOTTLE, PLASTIC in 1 CARTON (76420-588-10) / 10 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ciprofloxacin hydrochloride (3 mg/mL)

Linked Drug Pages (1)

ciprofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "045968a3-3bad-28cf-e063-6394a90a4fe1", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309307"], "spl_set_id": ["86c2ba30-9372-4e70-88a2-e6e1da07fa92"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76420-588-02)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76420-588-02", "marketing_start_date": "20230902"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76420-588-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76420-588-05", "marketing_start_date": "20230902"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76420-588-10)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76420-588-10", "marketing_start_date": "20230902"}], "brand_name": "ciprofloxacin", "product_id": "76420-588_045968a3-3bad-28cf-e063-6394a90a4fe1", "dosage_form": "SOLUTION", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "76420-588", "generic_name": "Ciprofloxacin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}], "application_number": "ANDA077568", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}