Ciprofloxacin And Dexamethasone Suspension/ Drops
NDC Package 46708-776-75

11-digit billing NDC: 46708077675
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ciprofloxacin And Dexamethasone suspension/ dropses is ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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. This formulation utilizes a suspension/ drops delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-776 and is authorized under FDA application ANDA217723.

Identification & Billing

NDC Package Code
46708-776-75
Package Description
1 BOTTLE in 1 CARTON / 7.5 mL in 1 BOTTLE
Product Code
46708-776
11-Digit Billing Format
46708077675

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 0.3% and dexamethasone 0.1% otic suspension 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 aureus and Pseudomonas aeruginosa.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217723
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-15-2026
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 46708-776-75 identifies a specific commercial package of 1 bottle in 1 carton / 7.5 ml in 1 bottle of Ciprofloxacin And Dexamethasone, a human prescription drug labeled by Alembic Pharmaceuticals Limited. 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 Alembic Pharmaceuticals Limited on October 15, 2026. The current certification is valid through December 31, 2027.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708077675. 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)
46708-776-75
11-Digit CMS (5-4-2)
46708-0776-75

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