NDC 24338-080 Otovel

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
24338-080
Proprietary Name:
Otovel
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Arbor Pharmaceuticals
Labeler Code:
24338
Start Marketing Date: [9]
04-29-2016
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 24338-080-14

Package Description: 1 POUCH in 1 CARTON / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE (24338-080-25)

Price per Unit: $17.05657 per EA

Product Details

What is NDC 24338-080?

The NDC code 24338-080 is assigned by the FDA to the product Otovel which is product labeled by Arbor Pharmaceuticals. The product's dosage form is . The product is distributed in a single package with assigned NDC code 24338-080-14 1 pouch in 1 carton / 14 vial, single-dose in 1 pouch / .25 ml in 1 vial, single-dose (24338-080-25). 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 Otovel?

This medication is used to treat ear infections for children who have a tube in their ears. This medication contains ciprofloxacin (a quinolone antibiotic) and fluocinolone (a corticosteroid). This product works by stopping the growth of bacteria and reducing ear inflammation and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Using any antibiotic when it is not needed can cause it to not work for future infections.

Which are Otovel UNII Codes?

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

Which are Otovel 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 Otovel?

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: 1792386 - ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % Otic Solution
  • RxCUI: 1792386 - ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution
  • RxCUI: 1792391 - Otovel 0.3 % / 0.025 % Otic Solution
  • RxCUI: 1792391 - ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution [Otovel]
  • RxCUI: 1792391 - Otovel (ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % ) Otic Solution

* Please review the disclaimer below.

Product Footnotes

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

[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".