Ciprofloxacin And Dexamethasone Suspension/ Drops
NDC Package 68071-3977-7

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, USP is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis,and Pseudomonas aeruginosa.Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureusand Pseudomonas aeruginosa. This formulation utilizes a suspension/ drops delivery system. Marketed by Nucare Pharmaceutical, Inc., this product is identified by NDC 68071-3977 and is authorized under FDA application ANDA210470.

Identification & Billing

NDC Package Code
68071-3977-7
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 7.5 mL in 1 BOTTLE, DROPPER
Product Code
68071-3977
11-Digit Billing Format
68071397707
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, USP is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis,and Pseudomonas aeruginosa.Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureusand Pseudomonas aeruginosa.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210470
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2022
Listing Expiration
12-31-2027
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 68071-3977-7 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 7.5 ml in 1 bottle, dropper of Ciprofloxacin And Dexamethasone, a human prescription drug labeled by Nucare Pharmaceutical, Inc.. 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 Nucare Pharmaceutical, Inc. on September 01, 2022. The current certification is valid through December 31, 2027.

How is this Nucare Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071397707. 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 (5-4-1)
68071-3977-7
11-Digit CMS (5-4-2)
68071-3977-07

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