ciprofloxacin

Generic: ciprofloxacin

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

Drug Facts

Product Profile

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

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Method Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 58657-676
Product ID 58657-676_41b40647-01ce-1916-e063-6394a90aaadd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208921
Listing Expiration 2026-12-31
Marketing Start 2020-08-12

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 58657676
Hyphenated Format 58657-676

Supplemental Identifiers

RxCUI
197511 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 ANDA208921 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (58657-676-01)
source: ndc

Packages (1)

58657-676-01 100 TABLET, COATED in 1 BOTTLE (58657-676-01)

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": "41b40647-01ce-1916-e063-6394a90aaadd", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["197511", "309309"], "spl_set_id": ["acb03e72-ce94-58c5-e053-2a95a90a683a"], "manufacturer_name": ["Method Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (58657-676-01)", "package_ndc": "58657-676-01", "marketing_start_date": "20200812"}], "brand_name": "Ciprofloxacin", "product_id": "58657-676_41b40647-01ce-1916-e063-6394a90aaadd", "dosage_form": "TABLET, COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "58657-676", "generic_name": "Ciprofloxacin", "labeler_name": "Method Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA208921", "marketing_category": "ANDA", "marketing_start_date": "20200812", "listing_expiration_date": "20261231"}