ciprofloxacin

Generic: ciprofloxacin hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-511
Product ID 72789-511_3ea0f42a-4723-5f6f-e063-6394a90a95d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077859
Marketing Start 2024-02-09
Marketing End 2028-02-29

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 72789511
Hyphenated Format 72789-511

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 (source: ndc)
Generic Name ciprofloxacin hydrochloride (source: ndc)
Application Number ANDA077859 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-30)
source: ndc

Packages (4)

72789-511-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-10) 72789-511-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-14) 72789-511-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-20) 72789-511-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-30)

Ingredients (1)

ciprofloxacin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Ciprofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ea0f42a-4723-5f6f-e063-6394a90a95d3", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["a914512b-9a4a-4c53-ab7a-2e2b1ea8a012"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-10)", "package_ndc": "72789-511-10", "marketing_end_date": "20280229", "marketing_start_date": "20250827"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-14)", "package_ndc": "72789-511-14", "marketing_end_date": "20280229", "marketing_start_date": "20250731"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-20)", "package_ndc": "72789-511-20", "marketing_end_date": "20280229", "marketing_start_date": "20250912"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-511-30)", "package_ndc": "72789-511-30", "marketing_end_date": "20280229", "marketing_start_date": "20250602"}], "brand_name": "Ciprofloxacin", "product_id": "72789-511_3ea0f42a-4723-5f6f-e063-6394a90a95d3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "72789-511", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA077859", "marketing_category": "ANDA", "marketing_end_date": "20280229", "marketing_start_date": "20240209"}