ciprofloxacin hydrochloride

Generic: ciprofloxacin hydrochloride

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

Drug Facts

Product Profile

Brand Name ciprofloxacin hydrochloride
Generic Name ciprofloxacin hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0493
Product ID 80425-0493_30caad43-7ca1-c06c-e063-6294a90afdeb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076593
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 804250493
Hyphenated Format 80425-0493

Supplemental Identifiers

RxCUI
309309
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 ANDA076593 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (80425-0493-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0493-2)
source: ndc

Packages (2)

80425-0493-1 20 TABLET, FILM COATED in 1 BOTTLE (80425-0493-1) 80425-0493-2 30 TABLET, FILM COATED in 1 BOTTLE (80425-0493-2)

Ingredients (1)

ciprofloxacin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Ciprofloxacin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30caad43-7ca1-c06c-e063-6294a90afdeb", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["30caadee-3255-e0e3-e063-6294a90a8061"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (80425-0493-1)", "package_ndc": "80425-0493-1", "marketing_start_date": "20250320"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0493-2)", "package_ndc": "80425-0493-2", "marketing_start_date": "20250320"}], "brand_name": "Ciprofloxacin Hydrochloride", "product_id": "80425-0493_30caad43-7ca1-c06c-e063-6294a90afdeb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "80425-0493", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin Hydrochloride", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076593", "marketing_category": "ANDA", "marketing_start_date": "20250320", "listing_expiration_date": "20261231"}