ciprofloxacin

Generic: ciprofloxacin hydrochloride

Labeler: chartwell rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin hydrochloride
Labeler chartwell rx, llc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ciprofloxacin hydrochloride 500 mg/1

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-309
Product ID 62135-309_410cec1e-83d0-dbed-e063-6394a90a6513
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076896
Listing Expiration 2026-12-31
Marketing Start 2021-04-13

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 62135309
Hyphenated Format 62135-309

Supplemental Identifiers

RxCUI
197511 197512 309309
UPC
0362135309206 0362135309107 0362135309053 0362135309015 0362135310202 0362135309282 0362135308018 0362135308209 0362135310288 0362135308285 0362135310509
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 hydrochloride (source: ndc)
Application Number ANDA076896 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-20)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-28)
source: ndc

Packages (5)

62135-309-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-01) 62135-309-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-05) 62135-309-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-10) 62135-309-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-20) 62135-309-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-28)

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": "410cec1e-83d0-dbed-e063-6394a90a6513", "openfda": {"upc": ["0362135309206", "0362135309107", "0362135309053", "0362135309015", "0362135310202", "0362135309282", "0362135308018", "0362135308209", "0362135310288", "0362135308285", "0362135310509"], "unii": ["4BA73M5E37"], "rxcui": ["197511", "197512", "309309"], "spl_set_id": ["6c64aa79-d087-4568-904c-3a0638b91e69"], "manufacturer_name": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-01)", "package_ndc": "62135-309-01", "marketing_start_date": "20210413"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-05)", "package_ndc": "62135-309-05", "marketing_start_date": "20210413"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-10)", "package_ndc": "62135-309-10", "marketing_start_date": "20210413"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-20)", "package_ndc": "62135-309-20", "marketing_start_date": "20210413"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-309-28)", "package_ndc": "62135-309-28", "marketing_start_date": "20210413"}], "brand_name": "Ciprofloxacin", "product_id": "62135-309_410cec1e-83d0-dbed-e063-6394a90a6513", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "62135-309", "generic_name": "Ciprofloxacin hydrochloride", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076896", "marketing_category": "ANDA", "marketing_start_date": "20210413", "listing_expiration_date": "20261231"}