ciprofloxacin hydrochloride

Generic: ciprofloxacin hydrochloride

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin hydrochloride
Generic Name ciprofloxacin hydrochloride
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-386
Product ID 69367-386_e679760f-b4d3-4a21-9d47-40c2355bc2c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076593
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

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 69367386
Hyphenated Format 69367-386

Supplemental Identifiers

RxCUI
197511 197512 309309
UPC
0369367386012
UNII
4BA73M5E37

Packaging Origin

Original Packager
true

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 hydrochloride (source: ndc)
Generic Name ciprofloxacin hydrochloride (source: ndc)
Application Number ANDA076593 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69367-386-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69367-386-05)
source: ndc

Packages (2)

69367-386-01 100 TABLET, FILM COATED in 1 BOTTLE (69367-386-01) 69367-386-05 500 TABLET, FILM COATED in 1 BOTTLE (69367-386-05)

Ingredients (1)

ciprofloxacin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Ciprofloxacin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e679760f-b4d3-4a21-9d47-40c2355bc2c0", "openfda": {"upc": ["0369367386012"], "unii": ["4BA73M5E37"], "rxcui": ["197511", "197512", "309309"], "spl_set_id": ["c47250c2-bece-46b5-8b3b-b7c97d9005d8"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69367-386-01)", "package_ndc": "69367-386-01", "marketing_start_date": "20240523"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69367-386-05)", "package_ndc": "69367-386-05", "marketing_start_date": "20240523"}], "brand_name": "Ciprofloxacin Hydrochloride", "product_id": "69367-386_e679760f-b4d3-4a21-9d47-40c2355bc2c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "69367-386", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin Hydrochloride", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076593", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20261231"}