ciprofloxacin

Generic: ciprofloxacin hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-045
Product ID 76420-045_ae77a7d7-f644-7b8f-e053-2a95a90a23e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077859
Listing Expiration 2026-12-31
Marketing Start 2007-04-26

Pharmacologic Class

Classes
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420045
Hyphenated Format 76420-045

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
  • 6 TABLET, FILM COATED in 1 BOTTLE (76420-045-06)
  • 10 TABLET, FILM COATED in 1 BOTTLE (76420-045-10)
  • 14 TABLET, FILM COATED in 1 BOTTLE (76420-045-14)
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-045-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-045-30)
source: ndc

Packages (5)

76420-045-06 6 TABLET, FILM COATED in 1 BOTTLE (76420-045-06) 76420-045-10 10 TABLET, FILM COATED in 1 BOTTLE (76420-045-10) 76420-045-14 14 TABLET, FILM COATED in 1 BOTTLE (76420-045-14) 76420-045-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-045-20) 76420-045-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-045-30)

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": "ae77a7d7-f644-7b8f-e053-2a95a90a23e5", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309309"], "spl_set_id": ["ae77a5c0-a2ae-770c-e053-2a95a90a6a96"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (76420-045-06)", "package_ndc": "76420-045-06", "marketing_start_date": "20200904"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (76420-045-10)", "package_ndc": "76420-045-10", "marketing_start_date": "20200904"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (76420-045-14)", "package_ndc": "76420-045-14", "marketing_start_date": "20200904"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-045-20)", "package_ndc": "76420-045-20", "marketing_start_date": "20200904"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-045-30)", "package_ndc": "76420-045-30", "marketing_start_date": "20200904"}], "brand_name": "Ciprofloxacin", "product_id": "76420-045_ae77a7d7-f644-7b8f-e053-2a95a90a23e5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "76420-045", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Asclemed USA, 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_start_date": "20070426", "listing_expiration_date": "20261231"}