ciprofloxacin

Generic: ciprofloxacin

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9928
Product ID 0143-9928_570d11c9-d12f-47fd-be83-37fa26d1262f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076558
Listing Expiration 2026-12-31
Marketing Start 2004-06-09

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 01439928
Hyphenated Format 0143-9928

Supplemental Identifiers

RxCUI
197511 197512 309309
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 (source: ndc)
Generic Name ciprofloxacin (source: ndc)
Application Number ANDA076558 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0143-9928-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0143-9928-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0143-9928-30)
source: ndc

Packages (3)

0143-9928-01 100 TABLET, FILM COATED in 1 BOTTLE (0143-9928-01) 0143-9928-05 500 TABLET, FILM COATED in 1 BOTTLE (0143-9928-05) 0143-9928-30 30 TABLET, FILM COATED in 1 BOTTLE (0143-9928-30)

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": "570d11c9-d12f-47fd-be83-37fa26d1262f", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["197511", "197512", "309309"], "spl_set_id": ["3b3d22dc-df09-4910-8c9b-1204eeedbd68"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0143-9928-01)", "package_ndc": "0143-9928-01", "marketing_start_date": "20040609"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0143-9928-05)", "package_ndc": "0143-9928-05", "marketing_start_date": "20040609"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0143-9928-30)", "package_ndc": "0143-9928-30", "marketing_start_date": "20040609"}], "brand_name": "Ciprofloxacin", "product_id": "0143-9928_570d11c9-d12f-47fd-be83-37fa26d1262f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "0143-9928", "generic_name": "Ciprofloxacin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076558", "marketing_category": "ANDA", "marketing_start_date": "20040609", "listing_expiration_date": "20261231"}