Ciprofloxacin Otic
NDC 42195-550

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 42195-550?
  4. Ciprofloxacin Otic Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ciprofloxacin Otic is a NDA-approved product labeled by Xspire Pharma, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 42195-550 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
42195-550
Proprietary Name:
Ciprofloxacin Otic
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Xspire Pharma, Llc
Labeler Code:
42195
Product Label ID:
d0125acf-1879-452d-ba29-c0f753653789
FDA Application Number: [6]
NDA021918
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-27-2012
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 42195-550?

The NDC code 42195-550 is assigned by the FDA to the product Ciprofloxacin Otic. This pharmaceutical product is labeled by Xspire Pharma, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 42195-550-14. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Ciprofloxacin Otic Solution is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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:

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Patient Education

Ciprofloxacin Otic


Ciprofloxacin otic solution (Cetraxal) and ciprofloxacin otic suspension (Otiprio) are used to treat outer ear infections in adults and children. Ciprofloxacin otic suspension (Otiprio) is also used in children during ear tube placement surgery to prevent infection or ear drainage. Ciprofloxacin otic is in a class of medications called quinolone antibiotics. It works by killing the bacteria that cause infection.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".