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NDC 71205-309 Ciprodex

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 71205-309?
  4. Ciprodex 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 discontinued by the firm.

Get all the details for National Drug Code (NDC) 71205-309 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
71205-309
Proprietary Name:
Ciprodex
Product Type: [3]
Labeler Name: [5]
Proficient Rx Lp
Labeler Code:
71205
Product Label ID:
9b4466c2-bd57-49dd-8957-74f22f70e913
FDA Application Number: [6]
NDA021537
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
08-04-2003
End Marketing Date: [10]
11-30-2021
Listing Expiration Date: [11]
11-30-2021
Exclude Flag: [12]
D
Code Navigator:

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Product Details

What is NDC 71205-309?

The NDC code 71205-309 is assigned by the FDA to the product Ciprodex which is product labeled by Proficient Rx Lp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 71205-309-75 1 bottle, dropper in 1 carton / 7.5 ml in 1 bottle, dropper. 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 Ciprodex?

This medication is used to treat bacterial ear infections. It is used to treat middle ear infections in children with ear tubes, as well as outer ear infections (also known as swimmer's ear) in children and adults. This medication contains a combination of ciprofloxacin (a quinolone-type antibiotic) and dexamethasone (an anti-inflammatory corticosteroid). This ear drop works by stopping the growth of bacteria and reducing ear swelling and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Which are Ciprodex UNII Codes?

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

Which are Ciprodex 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:

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Patient Education

Ciprofloxacin and Dexamethasone Otic


Ciprofloxacin and dexamethasone otic is used to treat outer ear infections in adults and children and acute (suddenly occurring) middle ear infections in children with ear tubes. Ciprofloxacin is in a class of medications called quinolone antibiotics. Dexamethasone is in a class of medications called corticosteroids. The combination of ciprofloxacin and dexamethasone works by killing the bacteria that cause infection and reducing swelling in the ear.
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Product Footnotes

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, 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".