ciprofloxacin

Generic: ciprofloxacin

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler advanced rx of tennessee, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0499
Product ID 80425-0499_30cb2b47-f440-5e22-e063-6294a90a8b3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077568
Listing Expiration 2026-12-31
Marketing Start 2025-03-20

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 804250499
Hyphenated Format 80425-0499

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 (80425-0499-1) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

80425-0499-1 1 BOTTLE, PLASTIC in 1 CARTON (80425-0499-1) / 5 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": "30cb2b47-f440-5e22-e063-6294a90a8b3d", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309307"], "spl_set_id": ["30cb2b42-aa4b-8cec-e063-6394a90aa615"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (80425-0499-1)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "80425-0499-1", "marketing_start_date": "20250320"}], "brand_name": "ciprofloxacin", "product_id": "80425-0499_30cb2b47-f440-5e22-e063-6294a90a8b3d", "dosage_form": "SOLUTION", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "80425-0499", "generic_name": "Ciprofloxacin", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20250320", "listing_expiration_date": "20261231"}