ciprofloxacin

Generic: ciprofloxacin hydrochloride

Labeler: denton pharma, inc. dba northwind pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin hydrochloride
Labeler denton pharma, inc. dba northwind pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Identifiers & Regulatory

Product NDC 70934-965
Product ID 70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076126
Marketing Start 2022-05-02
Marketing End 2026-08-31

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70934965
Hyphenated Format 70934-965

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 ANDA076126 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-06)
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-60)
source: ndc

Packages (5)

70934-965-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-06) 70934-965-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-14) 70934-965-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-20) 70934-965-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-30) 70934-965-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-60)

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": "e10891a7-9e65-ca14-e053-2995a90afa2f", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["de0b9579-fb85-e1ce-e053-2a95a90aeecb"], "manufacturer_name": ["Denton Pharma, Inc. DBA Northwind Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-06)", "package_ndc": "70934-965-06", "marketing_end_date": "20260831", "marketing_start_date": "20220502"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-14)", "package_ndc": "70934-965-14", "marketing_end_date": "20260831", "marketing_start_date": "20220502"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-20)", "package_ndc": "70934-965-20", "marketing_end_date": "20260831", "marketing_start_date": "20220502"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-30)", "package_ndc": "70934-965-30", "marketing_end_date": "20260831", "marketing_start_date": "20220516"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-965-60)", "package_ndc": "70934-965-60", "marketing_end_date": "20260831", "marketing_start_date": "20220609"}], "brand_name": "Ciprofloxacin", "product_id": "70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "70934-965", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076126", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20220502"}