Ciprofloxacin And Dexamethasone Suspension/ Drops
NDC Package 53746-831-53

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ciprofloxacin And Dexamethasone suspension/ dropses is ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below:  Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. This formulation utilizes a suspension/ drops delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 53746-831 and is authorized under FDA application ANDA216501.

Identification & Billing

NDC Package Code
53746-831-53
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 7.5 mL in 1 BOTTLE, PLASTIC
Product Code
53746-831
11-Digit Billing Format
53746083153
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic Suspension

Clinical Specifications

Proprietary Name
Ciprofloxacin And Dexamethasone
Non-Proprietary Name
Ciprofloxacin And Dexamethasone
Substance Name
Ciprofloxacin Hydrochloride; Dexamethasone
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below:  Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216501
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-26-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53746-831-53 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 7.5 ml in 1 bottle, plastic of Ciprofloxacin And Dexamethasone, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This suspension/ drops is formulated for auricular (otic) use and contains ciprofloxacin hydrochloride; dexamethasone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Of New York Llc on March 26, 2024. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53746083153. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53746-831-53
11-Digit CMS (5-4-2)
53746-0831-53

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.