ciprofloxacin

Generic: ciprofloxacin

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin
Generic Name ciprofloxacin
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-308
Product ID 69315-308_8217ec14-6498-4c35-a5a9-511b451b9459
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077568
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

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 69315308
Hyphenated Format 69315-308

Supplemental Identifiers

RxCUI
309307
UPC
0369315308028 0369315308059
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 ANDA077568 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-02) / 2.5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-05) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-10) / 10 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

69315-308-02 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-02) / 2.5 mL in 1 BOTTLE, PLASTIC 69315-308-05 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-05) / 5 mL in 1 BOTTLE, PLASTIC 69315-308-10 1 BOTTLE, PLASTIC in 1 CARTON (69315-308-10) / 10 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ciprofloxacin hydrochloride (3 mg/mL)

Linked Drug Pages (1)

ciprofloxacin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "8217ec14-6498-4c35-a5a9-511b451b9459", "openfda": {"upc": ["0369315308028", "0369315308059"], "unii": ["4BA73M5E37"], "rxcui": ["309307"], "spl_set_id": ["545527e7-05c7-4dbf-ab32-b3fa463d55b0"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69315-308-02)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69315-308-02", "marketing_start_date": "20181101"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69315-308-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69315-308-05", "marketing_start_date": "20181101"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69315-308-10)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69315-308-10", "marketing_start_date": "20181101"}], "brand_name": "ciprofloxacin", "product_id": "69315-308_8217ec14-6498-4c35-a5a9-511b451b9459", "dosage_form": "SOLUTION", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "69315-308", "generic_name": "Ciprofloxacin", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ciprofloxacin", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}], "application_number": "ANDA077568", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}