ciprofloxacin hydrochloride

Generic: ciprofloxacin hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin hydrochloride
Generic Name ciprofloxacin hydrochloride
Labeler asclemed usa, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-942
Product ID 76420-942_3175dedd-a620-17ae-e063-6294a90aa1e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019992
Listing Expiration 2026-12-31
Marketing Start 2004-05-07

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 76420942
Hyphenated Format 76420-942

Supplemental Identifiers

RxCUI
309307
UNII
4BA73M5E37

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 NDA019992 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (76420-942-03) / 2.5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (76420-942-05) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (76420-942-10) / 10 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

76420-942-03 1 BOTTLE, PLASTIC in 1 CARTON (76420-942-03) / 2.5 mL in 1 BOTTLE, PLASTIC 76420-942-05 1 BOTTLE, PLASTIC in 1 CARTON (76420-942-05) / 5 mL in 1 BOTTLE, PLASTIC 76420-942-10 1 BOTTLE, PLASTIC in 1 CARTON (76420-942-10) / 10 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ciprofloxacin hydrochloride (3 mg/mL)

Linked Drug Pages (1)

Ciprofloxacin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3175dedd-a620-17ae-e063-6294a90aa1e8", "openfda": {"unii": ["4BA73M5E37"], "rxcui": ["309307"], "spl_set_id": ["509b932e-9229-42c0-8a4c-f3257ffdca49"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76420-942-03)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76420-942-03", "marketing_start_date": "20250329"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76420-942-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76420-942-05", "marketing_start_date": "20250329"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76420-942-10)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76420-942-10", "marketing_start_date": "20250329"}], "brand_name": "Ciprofloxacin Hydrochloride", "product_id": "76420-942_3175dedd-a620-17ae-e063-6294a90aa1e8", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "76420-942", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin Hydrochloride", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}], "application_number": "NDA019992", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20040507", "listing_expiration_date": "20261231"}