ciprofloxacin hydrochloride

Generic: ciprofloxacin hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin hydrochloride
Generic Name ciprofloxacin hydrochloride
Labeler sandoz inc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-656
Product ID 61314-656_1c86f423-a99a-4e4d-9502-42799a9d40e6
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
quinolone antimicrobial [epc] quinolones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314656
Hyphenated Format 61314-656

Supplemental Identifiers

RxCUI
309307
UPC
0361314656100
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 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 (61314-656-05) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-10) / 10 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-25) / 2.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

61314-656-05 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-05) / 5 mL in 1 BOTTLE, PLASTIC 61314-656-10 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-10) / 10 mL in 1 BOTTLE, PLASTIC 61314-656-25 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-25) / 2.5 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": "1c86f423-a99a-4e4d-9502-42799a9d40e6", "openfda": {"upc": ["0361314656100"], "unii": ["4BA73M5E37"], "rxcui": ["309307"], "spl_set_id": ["ab52b14d-345b-47ff-a832-465caddd3801"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-656-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-656-05", "marketing_start_date": "20040507"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-656-10)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-656-10", "marketing_start_date": "20040507"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-656-25)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-656-25", "marketing_start_date": "20040507"}], "brand_name": "Ciprofloxacin Hydrochloride", "product_id": "61314-656_1c86f423-a99a-4e4d-9502-42799a9d40e6", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Quinolone Antimicrobial [EPC]", "Quinolones [CS]"], "product_ndc": "61314-656", "generic_name": "Ciprofloxacin Hydrochloride", "labeler_name": "Sandoz 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"}