ciprofloxacin

Generic: ciprofloxacin hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8546
Product ID 0615-8546_f9547f24-ff59-4087-8a87-dbfd6f37ad11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077859
Marketing Start 2024-02-09
Marketing End 2026-07-31

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 06158546
Hyphenated Format 0615-8546

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 BLISTER PACK (0615-8546-10)
  • 14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-14)
  • 20 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-20)
source: ndc

Packages (3)

0615-8546-10 10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-10) 0615-8546-14 14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-14) 0615-8546-20 20 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-20)

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": "f9547f24-ff59-4087-8a87-dbfd6f37ad11", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["60cbce40-4969-42a3-9645-2158261375ef"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-10)", "package_ndc": "0615-8546-10", "marketing_end_date": "20260731", "marketing_start_date": "20241015"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-14)", "package_ndc": "0615-8546-14", "marketing_end_date": "20260731", "marketing_start_date": "20241015"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BLISTER PACK (0615-8546-20)", "package_ndc": "0615-8546-20", "marketing_end_date": "20260731", "marketing_start_date": "20241015"}], "brand_name": "Ciprofloxacin", "product_id": "0615-8546_f9547f24-ff59-4087-8a87-dbfd6f37ad11", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "0615-8546", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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": "20260731", "marketing_start_date": "20240209"}