NDC 0078-0855 Cipro HC

Ciprofloxacin Hydrochloride And Hydrocortisone Suspension/ Drops Auricular (otic) - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-0855
Proprietary Name:
Cipro HC
Non-Proprietary Name: [1]
Ciprofloxacin Hydrochloride And Hydrocortisone
Substance Name: [2]
Ciprofloxacin Hydrochloride; Hydrocortisone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route(s): [4]
  • Auricular (otic) - Administration to or by way of the ear.
  • Labeler Name: [5]
    Novartis Pharmaceuticals Corporation
    Labeler Code:
    0078
    FDA Application Number: [6]
    NDA020805
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-15-1999
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0078-0855-26

    Package Description: 10 mL in 1 BOTTLE

    Price per Unit: $34.89055 per ML

    Product Details

    What is NDC 0078-0855?

    The NDC code 0078-0855 is assigned by the FDA to the product Cipro HC which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Cipro HC is ciprofloxacin hydrochloride and hydrocortisone. The product's dosage form is suspension/ drops and is administered via auricular (otic) form. The product is distributed in a single package with assigned NDC code 0078-0855-26 10 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Cipro HC?

    This medication is used to treat a variety of bacterial infections. Ciprofloxacin belongs to a class of drugs called quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for virus infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

    What are Cipro HC Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • CIPROFLOXACIN HYDROCHLORIDE 2 mg/mL - A broad-spectrum antimicrobial carboxyfluoroquinoline.
    • HYDROCORTISONE 10 mg/mL - The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

    Which are Cipro HC UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Cipro HC Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Cipro HC?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 213320 - Cipro HC 0.2 % / 1 % Otic Suspension
    • RxCUI: 213320 - ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension [Cipro HC]
    • RxCUI: 213320 - Cipro HC (ciprofloxacin 0.2 % / hydrocortisone 1 % ) Otic Suspension
    • RxCUI: 213320 - Cipro HC 2/10 Otic Suspension
    • RxCUI: 309305 - ciprofloxacin 0.2 % / hydrocortisone 1 % Otic Suspension

    Which are the Pharmacologic Classes for Cipro HC?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Ciprofloxacin and Hydrocortisone Otic


    Ciprofloxacin and hydrocortisone otic is used to treat outer ear infections in adults and children. Ciprofloxacin is in a class of medications called quinolone antibiotics. Hydrocortisone is in a class of medications called corticosteroids. The combination of ciprofloxacin and hydrocortisone works by killing the bacteria that cause infection and reducing swelling in the ear.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".