ciprofloxacin

Generic: ciprofloxacin hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-216
Product ID 51655-216_48d2ac12-e669-d797-e063-6394a90aaa7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077859
Marketing Start 2023-03-17
Marketing End 2027-02-28

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 51655216
Hyphenated Format 51655-216

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
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-25)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-52)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-53)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-84)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-87)
source: ndc

Packages (6)

51655-216-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-20) 51655-216-25 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-25) 51655-216-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-52) 51655-216-53 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-53) 51655-216-84 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-84) 51655-216-87 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-87)

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": "48d2ac12-e669-d797-e063-6394a90aaa7f", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["f80ab01d-2533-1b4c-e053-6294a90a6e6a"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-20)", "package_ndc": "51655-216-20", "marketing_end_date": "20270228", "marketing_start_date": "20230628"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-25)", "package_ndc": "51655-216-25", "marketing_end_date": "20270228", "marketing_start_date": "20230818"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-52)", "package_ndc": "51655-216-52", "marketing_end_date": "20270228", "marketing_start_date": "20240110"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-53)", "package_ndc": "51655-216-53", "marketing_end_date": "20270228", "marketing_start_date": "20230714"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-84)", "package_ndc": "51655-216-84", "marketing_end_date": "20270228", "marketing_start_date": "20230608"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-216-87)", "package_ndc": "51655-216-87", "marketing_end_date": "20270228", "marketing_start_date": "20230317"}], "brand_name": "Ciprofloxacin", "product_id": "51655-216_48d2ac12-e669-d797-e063-6394a90aaa7f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "51655-216", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "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": "20270228", "marketing_start_date": "20230317"}