ciprofloxacin hydrochloride

Generic: ciprofloxacin hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin hydrochloride
Generic Name ciprofloxacin hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-260
Product ID 82804-260_b281a5c0-5f3e-4e6f-86ac-ed7794aac64c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076593
Listing Expiration 2027-12-31
Marketing Start 2024-05-23

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 82804260
Hyphenated Format 82804-260

Supplemental Identifiers

RxCUI
309309
UPC
0382804260140
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
  • 14 TABLET, FILM COATED in 1 BOTTLE (82804-260-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE (82804-260-20)
source: ndc

Packages (2)

82804-260-14 14 TABLET, FILM COATED in 1 BOTTLE (82804-260-14) 82804-260-20 20 TABLET, FILM COATED in 1 BOTTLE (82804-260-20)

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": "b281a5c0-5f3e-4e6f-86ac-ed7794aac64c", "openfda": {"upc": ["0382804260140"], "unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["b281a5c0-5f3e-4e6f-86ac-ed7794aac64c"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (82804-260-14)", "package_ndc": "82804-260-14", "marketing_start_date": "20251230"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (82804-260-20)", "package_ndc": "82804-260-20", "marketing_start_date": "20251230"}], "brand_name": "Ciprofloxacin Hydrochloride", "product_id": "82804-260_b281a5c0-5f3e-4e6f-86ac-ed7794aac64c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "82804-260", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Proficient Rx LP", "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": "20240523", "listing_expiration_date": "20271231"}